CN105120935B - Patient interface and its manufacture method - Google Patents

Abstract

A kind of nasal patient interface, the entrance for forced air or breathable gas supply to be transported to patient airway, nasal patient interface includes：Cushion member, the cushion member includes holding structure and forms structure with the sealing for being permanently attached to holding structure；It could attach to the framing component of the holding structure；It is detachably attached to positioning and the rock-steady structure of the framing component；And engage mechanically and magnetically framing component to the headband folder positioned with rock-steady structure.Framework also includes the dividing plate for being configured to allow for the blow vent of the discharge of exhalation air and being configured to via the exhalation air of blow vent with the supply of forced air or breathable gas to isolate.

Description

Patient interface and its manufacture method

The cross reference of related application

The U.S. Provisional Application No. 61/811,385 submitted this application claims on April 12nd, 2013, on April 30th, 2013 U.S. Provisional Application No. 61/823192 that the U.S. Provisional Application No. 61/817674 submitted, on May 14th, 2013 submit, The U.S. Provisional Application that U.S. Provisional Application No. 61/888,357 that on October 8th, 2013 submits, on December 12nd, 2013 submit Number 61/915,320, the European non-provisional application number 13163546.8 submitted on April 12nd, 2013, on January 18th, 2013 submit Australian Provisional Application No. 2013900168, the Australian Provisional Application No. submitted on June 24th, 2013 2013902305th, the Australian Provisional Application No. 2013902945 and September in 2013 that August in 2013 is submitted on the 6th are submitted on the 12nd Australian Provisional Application No. 2013903509 rights and interests.Above-mentioned each application is integrally incorporated by reference The application.

Technical field

This technology is related to one or more of diagnosis, treatment and improvement of respiratory disorder, and is related to for preventing from exhaling Inhale the program of obstacle.Specifically, this technology is related to Medical Devices and they and is used to treat respiratory disorder and for preventing from exhaling Inhale the purposes of obstacle.

Background technology

The respiratory system of body contributes to gas exchanges.The entrance of patient airway is arrived in nose and mouth formation.

Air flue includes a series of branch pipes, and as branch pipe more gos deep into lung, branch pipe becomes narrower, shorter and quantity is huger Greatly.The major function of lung is gas exchanges, it is allowed to oxygen from air be moved to venous blood in and allow carbon dioxide Moved away from venous blood.Tracheae is divided into right principal bronchus and left principal bronchus, and right principal bronchus and left principal bronchus are most Bronchioli terminales is further separated into eventually.Bronchus constitutes the air flue of conducting, and is not involved in gas exchanges.The branch of air flue enters One step leads to alveolar bronchiole, and eventually arrives at bubble.The bubble area of lung is the place that gas exchanges occur, and It is referred to as breathing area.

The scope that respiratory disorder is present.

Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB), and it is with upper during sleep The occlusion of air duct is characterized.OSA is the area of tongue, soft palate and deutostoma pharynx wall by abnormal small epithelium healing and during sleeping Caused by the combination of the normal missing of Coordinating Muscle in domain.The condition causes impacted patient sometimes every night 200 to 300 It is secondary to be ceased breathing during the cycle that duration is usually 30 to 120 seconds.This typically results in excessive daydream, and this may lead Cause cardiovascular disease and brain damage.Although impacted people may not realize that the problem, over fat man especially in The syndrome is common obstacle in property.See United States Patent (USP) 4,944,310 (Sullivan).

Cheyne-stokes respiration (CSR) is the obstacle of the breath controller of patient, there is rhythmic alternate enhancing in CSR logical During wind and the ventilation that dies down, cause the deoxidation of arterial vascular repetition and reoxidize.Due to the hypoxgia that this is repeated, CSR It is probably harmful.In some patients, CSR is related to the awakening repeated from sleep, and the awakening of the repetition causes multiple sleep Interrupt, increase sympathetic nerve activity and increase afterload.See United States Patent (USP) 6,532,959 (Berthon-Jones)

Fat hypoventilation syndrome (OHS) is defined as tight in the case of other known causes of no hypoventilation The fat combination with chronic hypercapnia of awakening of weight.Symptom includes expiratory dyspnea, morning headache and excessive daytime sleepiness.

Chronic obstructive pulmonary disease (COPD) includes any one in the lower airway disease group with particular common characteristics. These diseases include lacking the normal elasticity of the increase of air moving resistance, breathing stage extension venting one's pent-up feelings and lung.COPD reality Example is pulmonary emphysema and chronic bronchitis.COPD is by chronic cigarette smoking (Major Risk Factors), occupational exposure, air pollution and base Caused by factor.Symptom includes：Motion expiratory dyspnea, chronic cough and white foam phlegm.

Neuromuscular disease (NMD) is broader term, and it is included via inherent muscle case directly or via god Through case many diseases of muscle injury function and imbalance indirectly.Some NMD patients are characterised by that progressive muscle is damaged, Progressive muscle damage causes locomotivity forfeiture, is tied to wheelchair, dysphagia, breathes muscle wealmess and final dead In breathing decay.Neuromuscular failure can be divided into quick progressive and progressive at a slow speed：(i) quick progressive obstacle：It is special Levy the muscle damage for being to weaken month by month and cause dead (such as amyotrophia (ALS) and progressive in teenager in the several years Muscular dystrophy (DMD))；(ii) variable or progressive sexual dysfunction at a slow speed：Be characterised by the muscle damage that weakens year by year and Only reduce the life-span to moderate (such as limb girdle, face shoulder arm and myotonia atrophica).The symptom bag of breathing decay in NMD Include：The having difficulty in breathing when increase of overall reduction, dysphagia, motion and rest, tired, drowsiness, morning headache and notice Neutralization emotional change is not collected.

Wall of the chest obstacle is to cause to breathe the thoracic deformity group of the combination deficiency between muscle and thoracic cavity.The usual feature of the obstacle It is limitation defect and the possibility with long-term hypercapnic respiratory failure.Scoliosis and/or scoliokyphosis Serious respiratory failure may be caused.The symptom of respiratory failure includes：Exertion dyspnea, peripheral edema, orthopnea, Repeated chest infection, morning headache, fatigue, poor sleeping quality and without appetite.

In addition, the individual of health can prevent respiratory disorder using the system and equipment.

3.2.1 system

A kind of known product for being used to treat SDB is the S9 physiological sleep therapy systems manufactured by ResMed.

3.2.2 therapy

Nose continuous positive airway (CPAP) therapy has been used to treatment obstructive sleep apnea (OSA).Before Carry be continuous positive airway as pneumatic splint, and can be by promoting soft palate and tongue forward and away from deutostoma pharynx wall To prevent epithelium healing occlusion.

Invasive ventilation (NIV) has been used to treatment OHS, COPD, MD and wall of the chest obstacle.

3.2.3 patient interface

Help the air in malleation by the use of patient interface such as nose cup, foil facial mask or nasal pillow to patient's gas The application of the supply of the entrance in road.Foil facial mask include such a mask, wherein, the mask have at least covering nostril and One sealing formation part of mouth or individually multiple sealings at least covering nostril and mouth form part.Known one is Row patient interface device, but most is limited by and makes us that uncomfortable, aesthetic undesirable, suitability is poor, be difficult to make With and particularly when long-time wear when or when patient is unfamiliar with system it is one or more of uncomfortable.Exclusively for work Pilot for a part for personal protection equipment or manage mask design for anesthetic may be when originally they apply It is patient, but it is undesirably uncomfortable for example to be worn when he falls asleep in the period of extension.

3.2.3.1 sealing forms structure

Patient interface generally includes seal molding structure.

A type of seal molding structure around patient interface periphery extend, and be intended to when utilize seal molding knot The face of structure and user engages come to being sealed during patient interface applying power to the facial of user Face to face.The seal molding Structure can include air or fluid filling pad or by such as rubber elastomer elastic sealing element molding Surface or profiled surface.Structure is formed using the sealing of the type, if adaptation is not enough, structure and face are formed in sealing Between there will be gap, and additional power will be needed to force patient interface against face to realize sealing.

Another type of sealing, which forms structure, includes the sheet packing of thin material, and the sheet packing is positioned in Around the periphery of mask, thus the face offer self sealss action when applying normal pressure in mask to user.Similar to The sealing of preceding type forms structure, if face is not good with matching between mask, additional power may be needed to realize Sealing, or mask may be revealed.If, may be in addition, sealing forms the shape of structure and the shape of patient is mismatched Wrinkle or bend in use, cause leakage.

Another form of sealing, which forms structure, can use adhesive to realize sealing.Some patients may feel regular Ground is inconvenient in their face coating and removal adhesive.

A series of patient interfaces are disclosed in the following patent application for transferring ResMed Co., Ltds to seal to form knot Structure technology：WO 1998/004,310, WO 2006/074,513 and WO 2010/135,785.

3.2.3.2 positioning and stably

Sealing for the patient interface of positive air pressure therapy forms structure by the power of correspondence air pressure to interrupt Sealing.Therefore, various technologies have been used for location sealing formation structure and for maintain sealing formed structure with it is facial appropriate The sealing relationship at position.

A kind of technology is to use adhesive.See such as U.S. Patent application US 2010/0000534.

Another technology is to use one or more bands and stability series band.Many frenulums are limited by the bad, body of adaptation Product is big, uncomfortable and is difficult with.

The rigid member of " rigid body " of being otherwise known as has previously been used for stretchable headband.It is permanent with rigid body known to one Ground is attached the problem of the fact that (such as lamination or suture) is to the big region for can uphold material is related and limits stretching for material Zhang Changdu, therefore the elastic characteristic of the whole headband of influence.Another problem is related to the cleaning of headband, and the cleaning of headband will need one Rise clean the rigid body and this can uphold material because they be each other permanent attachment together.

3.2.3.3 ventilate vocal imitation skill

Some form of patient interface systems include blow vent with the discharge for the carbon dioxide for allowing exhalation.Many ventilations Mouth is with noise.Other blow vents may in use block and provide insufficient discharge.Some blow vents may The sleep of the bed companion of patient is for example destroyed by noise or the air-flow of concentration.Some blow vents can not be cleaned thoroughly and necessary It is dropped after blocking.Some blow vents provide to be less than three months using short duration, and therefore by friable material system Make and cleaned or frequently cleaned with preventing, so as to encourage more frequently to replace blow vent.

ResMed Co., Ltds have developed a large amount of improved mask ventilation vocal imitation skills.See WO 1998/034,665, WO 2000/078,381st, US 6,581,594, US Patent Application, US 2009/0050156 and U.S. Patent application 2009/0044808。

Form (the ISO 17510-2 of the noise of existing mask:2007, the 10cm water column pressures at 1 meter)

(* only one samples, it is to use method of testing specified in ISO3744 in CPAP patterns on 10cm water columns Measurement)

The sound pressure level of various objects is listed herein below.

3.2.3.4 nasal pillow technology

A form of nasal pillow sees the Adam's circuit (Adam Circuit) manufactured by Puritan Bennett.It is another It is the United States Patent (USP) 4,782,832 (Trimble et al.) for transferring Puritan Bennett companies to plant nasal pillow or snuffing Theme.

ResMed Co., Ltds have manufactured the product of nasal pillow included below：SWIFT^TMNasal pillow mask, SWIFT II^TM Nasal pillow mask, SWIFT LT^TMNasal pillow mask, SWIFT FX^TMNasal pillow mask, LIBERTY foil facial masks.Transfer ResMed The following patent application of Co., Ltd describes nasal pillow mask：International patent application WO2004/073,778 (describes ResMed SWIFT^TMNasal pillow and other aspect), U.S. Patent application 2009/0044808 (describe ResMed SWIFT LT nasal pillows with And other aspects), international patent application WO 2005/063,328 and WO 2006/130,903 (describe ResMed LIBERTY^TMFoil facial mask and other aspect) and international patent application WO 2009/052,560 (describe ResMed SWIFT FX^TMNasal pillow and other aspects).

3.2.4 PAP equipment

Air in normal pressure is generally supplied to the air flue of patient by PAP equipment such as electric blower.Air blower Export and be connected to patient interface as described above via flexible conveyance conduit.

3.2.5 lower jaw resets

Lower jaw homing device (MRD) is a kind of therapeutic choice for sleep apnea.MRD is can be obtained from Medical-Dental Division , customized, adjustable appliance, its keep lower jaw during sleeping be in forward position.Machinery protuberance extension Space behind tongue, tension force is applied on oropharynx wall, to reduce collapsing and reducing maxilla vibration for air flue.

The content of the invention

This technology is related to the Medical Devices for providing and being used for diagnosing, improve, treat or prevent respiratory disorder, and it has what is improved Comfort level, cost, effect, use one or more of easness and manufacturability.

The device that one scheme of this technology is related to a kind of diagnosis for respiratory disorder, improves, treats or prevent.

Another scheme of this technology is related to a kind of device for being used to treat respiratory disorder, and it includes patient interface, air Loop and the air-source under normal pressure.

The method that another scheme of this technology is related to diagnosis for respiratory disorder, improves, treats or prevent.

Another scheme of this technology is related to a kind of patient interface, in the continuous malleation relative to environmental air pressure Breathable gas stream is sealed to the entrance for being transported to patient airway, the entrance at least includes the nostril of patient under power, wherein, patient Interface is configured as the respiratory cycle of patient during through patient sleeps, and maintaining treatment pressure in use is higher than surrounding air The about 4cm water columns of pressure are in the range of about 30cm water columns, to improve sleep disorders.In having individual example, suffer from Person's interface includes：Spacer assembly, it, which includes being suitable to forming the air flue of patient sealedly sealing, forms structure and in use It is pressurized to the pumping chamber under the pressure higher than environmental pressure；Positioning and rock-steady structure, it is used to maintain spacer assembly with enclosing Around the in sealing contact of the region of the entrance of patient airway, while maintaining the treatment pressure of the porch of patient airway；Gas Body discharges blow vent, and it is configured as the CO for allowing patient to breathe out₂The outside of patient interface is flow to, so as to being breathed out by patient CO₂Re-breathing minimize；And frame assembly, it is separably engaged spacer assembly and provided to positioning and stable knot The connection of structure.

One scheme of one form of this technology is a kind of patient interface, and it has the sealing that can be removed for cleaning Form structure.This technology is desirable to provide such a patient interface, and the patient interface is lighter than prior art patient interface quality, It is more unobtrusively and quieter than prior art patient interface in use than prior art patient interface.It would also be desirable to provide providing Such a patient interface, when connecting face shield assembly before start of the treatment, the patient interface is intuitively simultaneously for patients And the regulation of the patient interface and wear simple to treat.

Another scheme of one form of this technology is a kind of patient interface, and it, which has, to be connected via hardware to hardware The sealing navigated on patient interface forms structure.Another scheme of one form of this technology is a kind of the close of patient interface Envelope forms structure, and it can remove to clean in the case where not needing the connection of headband part of patient interface to disconnect.This Another scheme of one form of technology is a kind of patient interface that there is sealing to form structure, and it is formed by crush seal The sealing can be formed structure and be removed from frame assembly by the side of structure, and the holding for forming structure is sealed to allow to be arranged at Structure departs from from frame assembly.

Another scheme of one form of this technology is a kind of patient interface, for by forced air or breathable gas Supply is transported to the entrance of patient airway, and it includes：Cushion member, it has holding structure and is permanently attached to holding structure Sealing form structure；And framing component, wherein, holding structure and framing component repeatedly can be engaged and repeated each other Ground departs from, wherein, at least partly combine to form gas compartment by cushion member and framing component, wherein, in cushion member The increase of air pressure cause to seal the sealing force increase to be formed between structure and framing component, and wherein, sealing is formed Structure acts on two nostrils of patient using single throttle orifice.Sealing forms structure can be co-molded with holding structure.Can So that by shrinking two relative positions on the side of cushion member, cushion member is repeated with framing component and removably connect Close and depart from from framing component.Cushion member can be included when holding structure is attached to one another with framing component to framing component Sealed sealing lip is carried out, and when the air pressure increase in cushion member, sealing force increase.Sealing lip can be with it is close Envelope forms the continuous interior periphery edge of structural integrity.It is more firm that holding structure and framing component can form structure than sealing Property.Cushion member can include pumping chamber, and it, which has, is constructed and is configured as adjacent with the upper lip of patient in use put The rear wall put, and pumping chamber can be placed on holding structure and sealing is formed between structure.Patient interface can be wrapped further Positioning and rock-steady structure or connector are included, so as to which positioning and rock-steady structure are directly connected into framing component.Pumping chamber can be with Including sealing lip, sealing lip is placed in the supercharging join domain of pumping chamber, and sealing lip may be adapted to form cushion member Pneumostop between framing component.Sealing lip can be arranged on the part or whole interior periphery or part or whole of pumping chamber Around individual outer periphery.Patient interface may further include the part or whole interior periphery or part for being arranged on pumping chamber Or surrounding's additional seal lip of whole outer periphery.It is opposite that sealing lip forms structure with sealing at a certain angle and substantially Direction it is sagging from pumping chamber.Sealing lip can be constructed and be configured so that it substantially forms structure towards sealing It is deformable in direction so that when framework via supercharging join domain be attached to pumping chamber when can between pumping chamber and framework shape Into pneumostop.Sealing lip and pumping chamber can include an object.It can be fixed by co-molded or injection molding Ground attachment supercharging join domain and pumping chamber.Different materials, and pumping chamber can be included by being pressurized join domain and pumping chamber The material more soft than supercharging join domain can be included.Pumping chamber can include elastomeric material, and be pressurized join domain Thermoplastic polymer, high rigidity silicon, thermosetting resin or heat with the hardness higher than the elastomeric material of pumping chamber can be included Plastics elastomer.Be pressurized join domain and framework can by equivalent material manufacture into.At least one can be included by being pressurized join domain Individual keeping characteristics are to contribute to the connection with framework, and framework can include at least one complementary frame join domain to receive At least one corresponding keeping characteristics.In an example, when supercharging join domain is attached to framework, at least one is completed The engagement of individual keeping characteristics at least one framework join domain, which can be generated, may generate audible click.At least one Keeping characteristics can include the first keeping characteristics and the second keeping characteristics, and at least one framework join domain can include the One framework join domain and the second framework join domain.It can complementally set the first reservation special on the first framework join domain The size levied so that the second keeping characteristics can not be engaged with the first framework join domain.Keeping characteristics can be hook-shaped and frame Frame join domain is slit.

Another scheme of one form of this technology is a kind of patient interface for being used to provide breathable gas to patient. Patient interface includes：Pumping chamber with supercharging join domain；The sealing being arranged in pumping chamber forms structure, and sealing forms knot Structure acts on two nostrils of patient using single throttle orifice；And the frame including framework join domain and headband join domain Frame, wherein, framework join domain is configured at supercharging join domain and is attached to pumping chamber, and wherein, sealing lip Suitably form the pneumostop between supercharging join domain and framework join domain.Framework join domain can include at least one Keeping characteristics, to contribute to and be pressurized the connection of join domain, and be pressurized join domain can include at least one complementation even Region is connect to receive at least one corresponding keeping characteristics.At least one keeping characteristics can be hook-shaped, and this is hook-shaped to have Preceding surface and rear surface, and at least one complementary join domain can include importing surface and retention surface.

Another scheme of one form of this technology is a kind of patient interface, for will be by forced air or can tidal air Body supply is only transported to the entrance of the nose air flue of patient.Patient interface includes：Cushion member, cushion member includes holding structure Structure is formed with the sealing for being permanently attached to holding structure, sealing forms structure acts on patient using single throttle orifice two Individual nostril；And framing component, wherein, holding structure is repeatably engaged and repeatably taken off each other with framing component each other From；And wherein, the increase of the air pressure in cushion member causes to seal the sealing to be formed between structure and framing component Power increases.

Another scheme of one form of this technology is a kind of cushion member for patient interface, and patient interface is used for Forced air or breathable gas supply are transported to the entrance of patient airway.Cushion member includes：Holding structure, its be used for Framing component is repeatably engaged and repeatably departed from from framing component；And sealing forms structure, it is for good and all connected To holding structure, sealing forms two nostrils that structure acts on patient using single throttle orifice；Wherein, sealing formed structure by First material manufacture is formed, and holding structure is formed by the second material manufacture, and the second material has different from the first material Mechanical features, and the second material is more more rigid than the first material；And wherein, the increase of the air pressure in cushion member is led The sealing force increase that densification envelope is formed between structure and framing component.First material can be that silicones and the second material can be with It is the silicones with the hardness higher than the first material.Cushion member, which may further include, is placed on holding structure and sealing The pumping chamber formed between structure.First material can allow sealing to form structure to be readily adapted to accommodate finger pressure, and the second material Material can prevent holding structure to be readily adapted to accommodate finger pressure.

Another scheme of one form of this technology is a kind of cushion member for patient interface, and patient interface is used for Forced air or breathable gas supply are transported to the entrance of patient airway.Cushion member includes：Holding structure, its be used for Framing component is repeatably engaged and repeatably departed from from framing component；And sealing forms structure, it is for good and all connected To holding structure, sealing forms two nostrils that structure acts on patient using single throttle orifice；Wherein, sealing formed structure by First material manufacture is formed, and holding structure is by the second different from the first material and more more rigid than the first material material systems Make and form；And wherein, the first material allows sealing to form structure to be readily adapted to accommodate finger pressure, and the second material prevents from keeping Structure is readily adapted to accommodate finger pressure.

Another scheme of one form of this technology is a kind of cushion member for patient interface, and patient interface is used for Forced air or breathable gas supply are transported to the entrance of patient airway.Cushion member includes：Holding structure, its be used for Framing component is repeatably engaged and repeatably departed from from framing component；And sealing forms structure, it is connected to holding Structure, sealing forms two nostrils that structure acts on patient using single throttle orifice；Wherein, sealing forms structure by the first material Material is fabricated by, and holding structure by the second different from the first material and more more rigid than the first material material manufactures and Into；And wherein, holding structure has the continuous periphery edge on the leading flank contacted with framing component.

Another scheme of one form of this technology is a kind of patient interface, for by forced air or breathable gas Supply is transported to the entrance of patient airway, and the patient interface includes：Cushion member, it is acted on using single throttle orifice The sealing in two nostrils of patient forms structure；Framing component；And gas delivery conduit, it is from being permanently attached to framework structure The breathing equipment supply breathable gas of part.Gas delivery conduit includes：Spiral winding, it includes multiple adjacent windings, each Coil all separates one fixed width and with the outer surface for limiting coil diameter；And the web material coaxial with spiral winding, its Spiral winding is attached between adjacent windings in multiple adjacent windings and with the adjacent lines in multiple adjacent windings At least one folding part extended radially outwardly between circle, at least one folding part is limited by predetermined broken line.At least one The summit of individual folding part limits folding part diameter.When gas delivery conduit in the raw when, coil diameter is substantially equal to Folding part diameter, and adjacent windings are spaced apart in nature, and spiral coil and web material are by thermoplastic It is fabricated by.Gas delivery conduit includes a state in three different conditions：Nature, gas is defeated in nature Conduit is sent to include natural length；Extension state, gas delivery conduit is extended to along its longitudinal axis in extension state compares natural length Longer development length；And compressive state, gas delivery conduit is compressed along its longitudinal axis than naturally long in compressive state The shorter reduction length of degree.

Another scheme of one form of this technology is a kind of patient interface, for by forced air or breathable gas Supply is transported to the entrance of patient airway, and patient interface includes：Cushion member, it acts on patient using single throttle orifice The sealing in two nostrils form structure；Framing component；And gas delivery conduit, it is from being permanently attached to framing component Breathing equipment supplies breathable gas.Gas delivery conduit includes：Spiral winding, it includes multiple adjacent windings, each coil All separate one fixed width；And the web material coaxial with spiral winding, it is attached between adjacent windings in multiple adjacent windings It is connected to spiral winding and with least one folding extended radially outwardly between the adjacent windings in multiple adjacent windings Portion, at least one folding part is limited by predetermined broken line；First end sheathed catheter, it is used for conduit for good and all and can not It is rotationally connected to framing component；And the second end sheathed catheter, it is used for separably and rotatable with catheter adapter Ground is connected.Gas delivery conduit includes a state in three different conditions：Nature, gas is conveyed in nature Conduit includes natural length；Extension state, gas delivery conduit is extended to than natural length more along its longitudinal axis in extension state Long development length；And compressive state, gas delivery conduit is compressed along its longitudinal axis than natural length in compressive state Shorter reduction length.

Another scheme of one form of this technology is a kind of patient interface, for by forced air or breathable gas Supply is transported to the entrance of patient airway, and patient interface includes：Cushion member, it acts on patient using single throttle orifice The sealing in two nostrils form structure；Framing component；And gas delivery conduit, it is from being permanently attached to framing component Breathing equipment supplies breathable gas.Gas delivery conduit includes：Multiple coils, each coil separates one fixed width；And The coaxial web material with coil, it is attached to coil and with multiple coils between adjacent windings in multiple coils Adjacent windings between at least one folding part for extending radially outwardly, at least one folding part is limited by peak dot.Web material bag Include the protrusion adjacent with the first side of coil and the rake adjacent with the second side of coil, second side and first Side is relative.When gas delivery conduit in the raw when, the ratio of slope material from rake to adjacent peak dot of web material That nets is steeper to the gradient of adjacent peak dot from protrusion.

Another scheme of one form of this technology is a kind of patient interface, for by forced air or breathable gas Supply is transported to the entrance of patient airway, and patient interface includes：Cushion member, it acts on patient using single throttle orifice The sealing in two nostrils form structure；Framing component；And gas delivery conduit, it is from being permanently attached to framing component Breathing equipment supplies breathable gas.Gas delivery conduit includes：Spiral winding, it includes multiple adjacent windings, each coil All separate one fixed width；And the web material coaxial with spiral winding, it is attached between adjacent windings in multiple adjacent windings It is connected to spiral winding.When gas delivery conduit in the raw when, for separating the adjacent windings in multiple adjacent windings Width is substantially equal to the width of spiral winding.

Another scheme of one form of this technology is a kind of cushion member for patient interface, and patient interface is used for Forced air or breathable gas supply are transported to the entrance of patient airway, cushion member includes：Holding structure, its be used for Framing component is repeatably engaged and repeatably departed from from framing component；And sealing forms structure, it is connected to holding Structure, sealing forms two nostrils that structure acts on patient using single throttle orifice.Sealing forms structure by the first material system Make and form, and holding structure is formed by the second different from the first material and more more rigid than the first material material manufactures.It is close Envelope, which forms structure, has substantially planar lower wall, to mitigate the pressure on patient's upper lip.

One scheme of one form of this technology is a kind of method for manufacturing patient interface as described herein.This skill Art is desirable to provide a kind of lower manufacture method of complexity of the method than for manufacturing prior art patient interface, to improve system Efficiency is made, using less raw material and makes the less built-up time of operator's needs.

Another scheme of one form of this technology is a kind of patient interface, and it is molded as or otherwise structure Make as with the peripheral shape clearly limited, the peripheral shape is intended to match with the peripheral shape of expected wearer (i.e. patient) And it is similar and consistent with the face of expected wearer.

Another scheme of one form of this technology is the headband of a kind of positioning for patient interface and rock-steady structure Folder, the headband folder includes：Mechanical structure, its by the headband press from both sides be mechanically coupled to frame assembly headband tie point and Allow the headband folder relative to headband tie point rotation；Magnet, it makes the headband folder and the headband tie point magnetic Ground is engaged；And slit, it is used to receive the headband band passed through, wherein, when applying headband tension force, the machinery knot Structure prevents the headband is clipped in substantially flat with Frankfort horizontal direction (Frankfort horizontal direction) Linear displacement in capable direction, and wherein, the mechanical structure includes convex wall, and the convex wall, which is limited, to be suitable to receive the head Space with tie point.The convex wall is semicircle, and the headband tie point includes cylindrical portion, and the cylindrical part sets up separately There is the convex surface for being configured to engage the convex wall.The magnet can be maintained at by top layer plastic material and bottom plastic material In the headband folder.The mechanical structure can protrude convex wall away from the bottom plastic material.The convex wall can be from enclosing Circumferential section around the magnet protrudes.The convex wall can have semi-circular cross-section.The magnet can be packed completely In a plastic material.The slit can be elongated, and the slit makes its longitudinal axis be orientated and nominal vertical axle in use It is parallel.When headband folder is engaged with the headband tie point and applies headband tension force, the slit can be by described Frame assembly and it is unimpeded.The headband tie point can include magnet.The magnet of the headband tie point can be complete Packaging is in a plastic material.The magnet of the headband tie point can be packaged in the underarm of the frame assembly completely It is interior.The headband tie point can be from the raised convex surface of the underarm of the frame assembly so that when application headband tension force when institute Headband tie point is stated against the convex surface.When by adjusting the length of the headband band to apply headband tension force, the head Mechanical and magnetic the engagement with the underarm can be maintained with folder and is rotated relative to the underarm.The headband folder And/or the magnet of the headband tie point can be ferromagnet, permanent magnet or electromagnet.

Another scheme of one form of this technology is the framework for patient interface, and the patient interface is used to add Pressure air or breathable gas supply are transported to the entrance of patient airway.The framework includes：Main body；And at least one arm, It extends from the main body.At least one described arm is provided with headband tie point in the far-end of the arm.The headband connection Point includes magnet, and the magnet configurations are that the positioning with the patient interface and rock-steady structure are magnetically connected.

Another scheme of one form of this technology is the framework for patient interface, and the patient interface is used to add Pressure air or breathable gas supply are transported to the entrance of patient airway.The framework includes：Connectivity port, its be suitable to for Convey the conduit connection of forced air or breathable gas supply；Blow vent, it is configured to allow for coming from the patient interface Exhalation air or exhaled gas discharge；And dividing plate, it is configured to via the exhalation air of the blow vent Or exhaled gas is isolated with the supply of the forced air or breathable gas via the connectivity port.

Another scheme of one form of this technology is the frame assembly for patient interface, and the patient interface is used for Forced air or breathable gas supply are only transported to the entrance of the nose air flue of patient.The frame assembly includes：Ring； Underarm, it extends from the underarm tie point being positioned radially within the ring；Fastener, its upper bit in the ring The place of putting is extended back from the ring；And upper arm, it extends from upper arm tie point in the far-end of the fastener, made Obtain the position that the underarm tie point is in before the upper arm tie point.The upper arm tie point and the underarm tie point Predetermined distance is separated, so that the face of relatively described patient provides maximum inclination scope for the frame assembly.

Another scheme of one form of this technology is the method for dismantling patient interface, and the patient interface is used for Forced air or breathable gas supply are transported to the entrance of patient airway.Methods described includes extruding or collapsed seal shape Into the side of structure, departed from allowing the sealing to form structure from framework.

Another scheme of one form of this technology is a kind of method for manufacturing patient interface.

Certainly, a part of of these schemes can form the subscheme of this technology.In addition, different subschemes and/or side One of case can in different ways combine and also constitute the additional scheme or subscheme of this technology.

By consider be included in specification described below, summary, drawings and claims in information, this technology its He will be evident feature.

Brief description of the drawings

By way of example rather than the mode of limitation shows this technology, in the figure of accompanying drawing, wherein similar accompanying drawing Mark refers to similar element, including：

5.1 treatment system

Fig. 1 a show the system according to this technology.The patient 1000 for wearing patient interface 3000, which receives, comes from PAP equipment 4000 air being under normal pressure supply.Air from PAP equipment 4000 is humidified and edge in humidifier 5000 Air loop 4170 is delivered to patient 1000.

Fig. 1 b are shown uses the PAP equipment 4000 with nose cup just on patient 1000.

Fig. 1 c are shown uses the PAP equipment 4000 with foil facial mask just on patient 1000

5.2 therapy

5.2.1 respiratory system

Fig. 2 a show the overview of human respiratory system, including nasal cavity and oral cavity, larynx, vocal fold, oesophagus, trachea-bronchial epithelial cell, Lung, alveolar sac, heart and diaphragm.

Fig. 2 b show the view of mankind's epithelium healing, including nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, On lip, under lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal fold, oesophagus and tracheae.

5.2.2 facial dissection

Fig. 2 c be with the facial front view of multiple surface anatomy features recognized, including on lip, upper lip, lower lip, Under lip, wide mouth, intraocular corner of the eyes angle, the wing of nose, nasolabial groove and bicker.

Fig. 2 d are the side views with the head of multiple surface anatomy features recognized, including glabella, the nasion, snout Point, nose bottom point, on lip, under lip, point on chin, the bridge of the nose, on ear, under ear.It is front and rear above-below direction that further indicates.

Fig. 2 e are the further side views on head.Show the apparent position of Frankfort level and nasal labial angle.

Fig. 2 f show the upward view of nose.

Fig. 2 g show the side view of the surface characteristics of nose.

Fig. 2 h show the sub-dermal structures of nose, including lateral nasal cartilage, nasal septal cartilage, greater alar cartilage, the wing of nose are small Cartilage and fibrofatty tissue.

Fig. 2 i show the middle dissection of nose, approximate several millimeters of sagittal planes, the nasal septum for showing greater alar cartilage Cartilage and medial angle and other.

Fig. 2 j show the front view of skull, including frontal bone, temporal bone, nasal bone and cheekbone.Show concha, maxilla, under Jawbone and mental protuberance.

Fig. 2 k show the side view of skull using the profile and multiple muscle on the surface of head.Show following bone： Frontal bone, sphenoid bone, nasal bone, cheekbone, maxilla, mandibular, parietal bone, temporal bone and occipital lobe.Show mental protuberance.Show following flesh Meat：Digastric muscle, masseter, nutator and cucullaris.

Fig. 2 l show the preceding outer side view of nose.

5.3 PAP equipment and humidifier

Fig. 3 a show the exploded view of the PAP equipment of an example according to this technology.

Fig. 3 b show the stereogram of the humidifier of a form according to this technology.

Fig. 3 c show the schematic diagram of the pneumatic circuit of the PAP equipment of a form according to this technology.Show upstream With the direction in downstream.

5.4 patient interface

Fig. 4 shows the tubulature in the raw of an example according to this technology.

Fig. 5 shows the side view of the tubulature in compressive state of an example according to this technology.

Fig. 6 shows the side view of the tubulature in elongated condition of an example according to this technology.

Fig. 7 shows the side view of the tubulature in case of bending of an example according to this technology.

Fig. 8 shows the transversal of according to an example of this technology tubulature along the line 163-163 cuttings shown in Fig. 7 Face view.

Fig. 9 shows the stereogram of the tubulature in bending and elongated condition of an example according to this technology.

Figure 10 to 14 show according to the form of this technology be elongated 30mm, 60mm, 90mm and 120mm away from From conduit, wherein, the lower end of conduit is maintained at fixed position, the longitudinal axis of conduit start at its lower end with elongation before stretching Length direction is vertical.

Figure 15 to 19 shows the ResMed for the distance for being elongated 30mm, 60mm, 90mm and 120mm^TM Swift FX^TMNose Pillow top cover conduit, wherein, the lower end of conduit is maintained at fixed position, before the longitudinal axis of conduit starts at its lower end with elongation Prolonging direction is vertical.

Figure 20 to 24 shows the Philips for the distance for being elongated 30mm, 60mm, 90mm and 120mm^TM Respironics^TM GoLife^TMNasal pillow mask conduit, wherein, the lower end of conduit is maintained at fixed position, and the longitudinal axis of conduit exists It is vertical with the prolonging direction before elongation starts at its lower end.

Figure 25 to 29 shows the Philips for the distance for being elongated 30mm, 60mm, 90mm and 120mm^TM Respironics^TM Wisp^TMNose cup conduit, wherein, the lower end of conduit is maintained at fixed position, and the longitudinal axis of conduit is in its lower end Locate vertical with the prolonging direction before elongation starts.

Figure 30 is to be suffered from according to first example of this technology to show headband approximate relative location in use The stereogram of the patient interface shown on person's head.

Figure 31 to 34 is for showing the suitable of the illustrative steps for the patient interface for wearing the first example according to this technology Sequence view.

Figure 35 is the stereogram for being shown partially in the patient interface of the tubulature of the first example according to this technology.

Figure 36 is the stereogram for showing the patient interface of the whole tubulature of the first example according to this technology.

Figure 37 is the approximate relative position in use to show headband for showing the second example according to this technology The stereogram for the patient interface put and shown on patient's head.

Figure 38 to 41 is for showing the suitable of the illustrative steps for the patient interface for wearing the second example according to this technology Sequence view.

Figure 42 to 49 shows the different views of the framework of the 3rd example according to this technology.

Figure 50 to 52 shows the different views that feature is prevented according to the outflow of an example of this technology.

Figure 53 is the side isometric view of the framework for patient interface of the 4th example according to this technology.

Figure 54 is the side isometric view of framework, the patient for being shown partially in being connected to the 4th example according to this technology The tubulature of the framework of interface.

Figure 55 is the front view of Figure 53 framework.

Figure 56 is the side view of Figure 54 framework.

Figure 57 is the upward view of Figure 54 framework.

Figure 58 is the top view of Figure 54 framework.

Figure 59 is the side isometric view of the framework for patient interface of the 5th example according to this technology, and ventilation is not shown Mouthful.

Figure 60 is the front view of Figure 59 framework.

Figure 61 is the side view of Figure 59 framework.

Figure 62 is the upward view of Figure 59 framework.

Figure 63 is the top view of Figure 59 framework.

Figure 64 is to be suffered from according to the 4th example of this technology to show headband approximate relative location in use The stereogram of the patient interface shown on person's head.

Figure 65 is to be suffered from according to the 4th example of this technology to show headband approximate relative location in use The front view of the patient interface shown on person's head.

Figure 66 is to be suffered from according to the 4th example of this technology to show headband approximate relative location in use The side view of the patient interface shown on person's head.

Figure 67 is to be suffered from according to the 4th example of this technology to show headband approximate relative location in use The rearview of the patient interface shown on person's head.

Figure 68 be approximate relative location in use padded showing nose according to the 4th example of this technology and The close-up, perspective view of the patient interface shown on patient's head,.

Figure 69 is the vertical of the patient interface of the gasket clip for being used for display and framework apart of the 4th example according to this technology Body figure.

Figure 70 is for being shown partially according to the positioning for being positioned at patient interface of the 4th example of this technology and stably The stereogram of headband folder on the following counterband tape of structure.

Figure 71 is that the sealing of the patient interface of the 4th example according to this technology forms the top plan view of structure.

Figure 72 is the stereogram of the patient interface of the 4th example according to this technology.

Figure 73 is that the sealing of the patient interface of the 4th example according to this technology forms the rearview of structure.

Figure 74 Figure 73 sealing forms the zoomed-in view of structure.

Figure 75 is the rearview of the spacer assembly of the 4th example according to this technology.

Figure 76 is the rearview of the spacer assembly of the 4th example according to this technology.

Figure 77 shows the zoomed-in view of Figure 53 framework, shows the magnet being positioned on underarm.

Figure 78 shows the patient interface according to this technology, including is molded into leading for tubulature shown in Figure 54 to 58 Framework on pipe sleeve, patient interface further comprises the spacer assembly engaged in separably mode with frame seal.

Figure 79 shows the patient interface of another example according to this technology.The patient interface includes positioning and stable knot Structure, the positioning and rock-steady structure include magnet.The positioning and rock-steady structure be separably engaged the framework with blow vent and It is molded on the sheathed catheter of tubulature.The framework is separably engaged with spacer assembly.

Figure 80 is the cross-sectional perspective view of the spacer assembly of the 4th example according to this technology.

Figure 81 is the cross-sectional side view of the spacer assembly of the 4th example according to this technology.

Figure 82 is the exploded perspective view of the patient interface for showing detachable member of an example according to this technology.

Figure 83 is that the decomposition of the frame assembly without tubulature and spacer assembly of the 4th example according to this technology is stood Body figure.

Figure 84 is the stereogram of the patient interface of the 4th example according to this technology.

Figure 85 is the rear perspective view of the patient interface of the not shown headband band of the 4th example according to this technology.

Figure 86 is the side perspective of the patient interface for showing the component being attached to one another of the 4th example according to this technology Figure.

Figure 87 is the frontal perspective of the patient interface for showing the component being attached to one another of the 4th example according to this technology Figure.

Figure 88 is the rear lower stereogram of the patient interface of the not shown headband band of the 4th example according to this technology.

Figure 89 is the anterior viewgraph of cross-section of the amplification of the pumping chamber of a form according to this technology.

Figure 90 is the anterior viewgraph of cross-section of the amplification of the pumping chamber of a form according to this technology.

Figure 91 is the enlarged cross-sectional view for being pressurized join domain.

Figure 92 is the side cross-sectional view of the amplification of the pumping chamber of a form according to this technology.

Figure 93 is the viewgraph of cross-section of coupling part and framework join domain, wherein, pumping chamber and framework are not engaged.

Figure 94 is the viewgraph of cross-section of coupling part and framework join domain, wherein, pumping chamber and contact therewith but not It is fully engaged.

Figure 95 is the viewgraph of cross-section of coupling part and framework join domain, wherein, pumping chamber and framework are almost complete each other It is complete to be coupled so that keeping characteristics are deflected.

Figure 96 is the viewgraph of cross-section of coupling part and framework join domain, wherein, pumping chamber and framework engagement but every Open with so that keeping characteristics are deflected.

Figure 97 is the viewgraph of cross-section of coupling part and framework join domain, wherein, pumping chamber and framework are fully engaged.

Figure 98 to 101 shows the different views of the framework of an example according to this technology.

Figure 102 to 105 shows the different views of the supercharging join domain according to an example of this technology

Figure 106 is frame assembly and is connected to the cross-sectional side view of the sheathed catheter of the gas delivery conduit of frame assembly.

Figure 107 is the cross-sectional side view for showing the sheathed catheter of gas delivery conduit.

Figure 108 is the enlarged cross-sectional view for showing a part for Figure 107 sheathed catheter.

Figure 109 is the cross-sectional side view pressed from both sides according to the positioning of a form of this technology and the headband of systems stabilisation.

Figure 110 is the rearview of the spacer assembly of a form according to this technology.

Figure 111 is to include being used for isolating in input forced air path with the air flow path of the output waste gas to blow vent The cross-sectional side view of the frame assembly of structure.

Figure 112 be according to the form of this technology and the magnet being embedded in the underarm of frame assembly magnetically and machine The cross-sectional side view of the headband folder engaged tool.

Figure 113 is the viewgraph of cross-section of the frame assembly of a form according to this technology.

Figure 114 is the enlarged cross-sectional view for showing a part for Figure 113 frame assembly.

Figure 115 to 121 is shown to be used to being arranged to patient interface into order on patient according to a form of this technology The step of.

Figure 122 to 123 is shown is used for the order that removes patient interface from patient according to the form of this technology Step.

Figure 124 to 126 shows the different steps for being used to dismantle patient interface of a form according to this technology.

Figure 127 to 130 shows the different steps for being used to recombinate patient interface of a form according to this technology.

Figure 131 to 137 shows the different steps of the patient interface of a form according to this technology.

Embodiment

Before this technology is more fully described, it is understood that the technology can change, tool as described herein is not limited to Body example.It is also understood that the term used in disclosure herein be merely to illustrate the purpose for the instantiation being discussed herein and It is not intended for limitation.

6.1 treatment system

In one form, this technology includes the device for being used to treat respiratory disorder.As shown in Fig. 1 a, the device It can include being used for supplying the pressurized breathable gas of such as air via the air loop 4170 for leading to patient interface 3000 The flow generator or air blower of patient 1000.

6.2 therapy

In one form, this technology includes the method for being used to treat respiratory disorder, and this method includes applying normal pressure To the air flue of patient 1000 entrance the step of.

6.2.1 OSA nasal CPAP

In one form, this technology includes treating patient's by the way that the continuous positive airway pressure of nose is put on into patient The method of obstructive sleep apnea

6.3 patient interfaces 3000

Reference picture 82, includes following functions scheme according to the non-invasive patient interface 3000 of this technology scheme： Frame assembly 3001, including sealing form the pad of structure 3100 (see Figure 73 to Figure 76, Figure 80 and Figure 81) and pumping chamber 3200 Component 3002 (see Figure 71), and positioning and rock-steady structure 3300 (see Figure 72)., can be by one or more in some forms Physical unit provides function scheme.In some forms, a physical unit can provide one or more functions scheme.Use In, sealing forms the entrance that structure 3100 is arranged around the air flue of patient 1000 so that contribute to the air under normal pressure Supply air flue.Sealing, which forms structure 3100, can also be commonly referred to as pad.

Reference picture 69, Figure 71 and Figure 72, frame assembly 3001 are used as tubulature 4180, spacer assembly 3002 and positioning The central hub (central hub) being connected thereto with rock-steady structure 3300 with removable form or more permanent form. Frame assembly 3001 has the connectivity port 3600 for the tubulature 4180 for being used to be connected to air loop 4170 (see Figure 53).At this In one example of technology, frame assembly 3001 includes sub-component, tubulature 4180 and the blow vent 3400 of framework 3310.

Framework 3310 can also be commonly referred to as framework underframe (frame chassis).Framework 3310 separably with pad set Part 3002 engages to provide and position the four point attachment with rock-steady structure 3300.Framework 3310 further comprises surrounding connectivity port 3600 porous blow vent 3400.Tubulature 4180 include it is overmolded to or be otherwise connected to the one of tubulature 4180 The non-rotating sheathed catheter 10610 at end.Sheathed catheter 10610 it is overmolded to or be otherwise connected to the connection end of framework 3310 Mouth 3600, so that the pumping chamber 3200 with spacer assembly 3002 is in fluid communication.

In an example, tubulature 4180 is directly attached or with it in the case of no use bend pipe or swivel elbow Its mode is arranged at framework 3310, so provides the setting for the more light weight for having lacked a part.In an example, tubulature 4180 can provide enough pliabilities to perform the function similar to bend pipe or swivel elbow, with to the conduit on specific direction Torque is decoupled.

In an example, pumping chamber 3200 and sealing, which form structure 3100 and be molded, is integrated.In another example In, they are formed as two or more independent parts.

In Figure 71, spacer assembly 3002 can include sealing area 251 or sealing duct set, side wall or sidewall areas 457, holding structure 3242 and attachment area 158.In an example, spacer assembly 3002 can be by flexible elastomer or rubber Glue is formed.Similarly, spacer assembly 3002 can include sealing area 251, side wall or sidewall areas 457 and special including retaining Levy 3244,3245 holding structure 3242.Keeping characteristics 3244,3245 can be adapted for adaptation by being positioned at framework 3310 The form (for example, seeing Figure 98 and Figure 99) of the crook 3246 of upper corresponding frame join domain 3312,3313, for by pad set Part 3002 is bonded to framework 3310 in a detachable fashion.

6.3.1 sealing forms structure 3100

In a kind of form of this technology, sealing forms the offer sealing of structure 3100 and forms surface, and can be extraly Padding function is provided.

Forming structure 3100 according to the sealing of the non-invasive patient interface 3000 of this technology can be by such as silicones Soft, flexible elasticity material is constituted.Sealing, which forms structure 3100, can form for the air from PAP equipment 4000 A part for sealed pathway, and be configured and disposed to shape and be paired around two nostrils without being positioned partially inside nose The sealing of patient airway.The sealing of such as nose pad or nose stretcher forms structure 3100 and acts on two using single throttle orifice Nostril.Nose pad is the soft silicone pad being for good and all overmolded onto in plastics clamp assembly/holding structure 3242.Pad set Part 3002 includes the holding structure 3242 for being used to be maintained at framework 3310 on the wall of pumping chamber 3200.Sealing forms structure 3100 As the interface between frame assembly 3001 and patient facial region.Sealing forms structure 3100 and provides the He of air chamber/pumping chamber 3200 It is around patient nose, for the conveying to the defined PAP (positive airway pressure) of patient's nose air flue be necessary sky Hermetic seal.

Sealing forms structure 3100 and sealing is formed under the bridge of the nose.This is intended to cause patient interface 3000 not substantially, but comfortably And stably with avoid leakage.Sealing forms structure 3100, and there is the modified double wall design for comfort seal (that is, to have There is subgaskets (undercushion) structure 265).This is double-walled pad diaphragm design.Thin, flexible outer membrane 260 is swollen It is swollen and meet with facial surface.End liner mat structure or internal diaphragm 265 provide secondary structure support to strengthen sealing.

Reference picture 69, Figure 71 and Figure 80 are to Figure 83, in a kind of form of this technology, and spacer assembly 3002 includes close Envelope forms structure 3100 and the supercharging join domain 3240 with holding structure 3242.Spacer assembly 3002 can have butt Coniform shape.Holding structure 3242 has the wide guarantor for being used for engaging with the corresponding join domain 3312,3313 on framework 3310 Stay feature 3244 and narrow keeping characteristics 3245.Sealing, which forms structure 3100, can include sealing flange 3110 and support lugn 3120.Sealing flange 3110 can include with the thickness less than about 1mm, be, for example, about 0.25mm to about 0.45mm Thickness relative thin component.Support lugn 3120 can be relatively thicker than sealing flange 3110.Support lugn 3120 be or Element including spring-like and in use support sealing flange 3110 from bending.In use, sealing flange 3110 easily can respond to promote to the system pressure acted on the bottom surface of pumping chamber 3200 in pumping chamber 3200 Sealing flange 3110 with the tight seal of patient facial region into engaging.Pumping chamber 3200 by such as silicones flexible material system Into.

Reference picture 81, in a kind of form of this technology, spacer assembly 3002 has sealing flange 3110.Sealing flange 3110 include the barrier film 260-1 of sealing area 251, and support lugn 3120 includes the end liner mat structure or branch of sealing area 251 Hold band 265.Sealing flange 3110 extends around the periphery 3210 of pumping chamber 3200.It is convex that support lugn 3120 is arranged on sealing Edge 3110 and increase room 3200 margin 3220 between, and at least in part pumping chamber 3200 periphery 3210 week Enclose extension.

In a kind of form of this technology, sealing, which forms structure 3100, includes top sealed portion 3102 and sealing portion point 3104 (see Figure 81).Point 3104 positioning for example adjacent to each other of top sealed portion 3102 and sealing portion, and region can be with Mixed with another region.

Top sealed portion 3102

Top sealed portion 3102 is configured and disposed on a part of nasal cartilages skeleton of nose form sealing.In a reality Example in, top sealed portion 3102 by relative thin material construction form, such as by the thin slice, flange or barrier film of material, for example by Thermoplastic elastomer (TPE) or silicones, and further for example by being easy in response to finger pressure gently when not in use The material of bending or bending is constructed.Depending on the shape of the nose using top sealed portion 3102, top sealed portion 3102 Relatively narrow width can engage to form sealing with the bridge of the nose.The relatively wide part of top sealed portion 3102 can with side nose The adjacent skin engagement of cartilage is to form sealing.

Top sealed portion 3102 is not designed to cover whole nose.In an example, for example hermetic unit 3102 is constructed Be set to it is thin and flexible, to adapt to different bridge of the noses height.In this fashion, adding can obtain good close The facial scope of envelope.

Further, for given face and nose, if the pliability of top sealed portion 3102 is it is meant that for example It can be moved in response to the mobile pumping chamber 3200 of tubulature 4180, then sealing can be maintained.

When top sealed portion 3102 is constructed so that top sealed portion 3102 in use does not cover nasal bone, based on how It is definite to use patient interface 3000 and the specifically facial size and dimension of patient, the specific part of top sealed portion 3102 A part of nasal bone on some faces can be covered.In alternative form, top sealed portion 3102 is configured and disposed to Sealing is formed in use on nasal bone.

Sealing portion point 3104

Sealing portion point 3104 is configured and disposed on a part of upper lip of patient 1000 form sealing, and near Few a part of sealing force is oriented to the jawbone of patient 1000.In use, a part of sealing portion point 3104 is positioned at postalifera And near wing of nose summit.

In one form, sealing portion point 3104 is configured to avoid the excess pressure on upper tooth or upper gum.One In individual example, sealing portion point 3104 does not extend upwardly to wing of nose summit along bone (such as the volume of jawbone is dashed forward), but should Understand that it may extend along bone in other examples.

Sealing portion point 3104 can be by for example by silicone rubber or thermoplastic elastomer (TPE), such as with about 1mm Thin slice, edge or flange to 2mm single, relatively thicker material are constructed.In one form, sealing portion point 3104 can be constructed by dual thin slice, edge or flange, and for example another with a kind of and relative thick of relative thin carrys out structure Make.Alternatively, sealing portion point 3104 can be constructed by gel-filled bladder.

" W " shape region

Figure 75 shows the spacer assembly 3002 according to another example of this technology.In this example, spacer assembly 3002 are included in substantially " W " shape in upper lip area 255, i.e., along the outside of the barrier film 260-2 in upper lip area 255 (under) substantially " W " shape at edge 260 (o).

In Figure 76, in another example, spacer assembly 3002 includes having along the barrier film in upper lip area 255 The sealing of substantially " W " shape at 260-3 inside (on) edge 260 (i) and barrier film 260-3 outside (under) edge 260 (o) Form structure 3100.In one form, " W " of upper lip area 255 is partly configured and disposed to so that seal shape in use Into structure 3100 upwards (to higher position) in the case of movement, the center section of " W " rests on nose bottom point or nose pillar in use On, leaving a void under nostril or around each left and right postalifera or space (its subgaskets 265 inward flange and Between the inner surface of pumping chamber 3200).

In another example, as shown in Figure 110, spacer assembly 3002 can be included in edge in upper lip area 255 Barrier film 260-3 inside (on) substantially " W " shape at edge 260 (i) and along barrier film 260-3 outside (under) edge The generally flat or flat shape of 260 (o).In an example, in Figure 110 generally flat or plane outward flange or basic Upper flat lower wall can mitigate the pressure on patient's upper lip.

In an example, hermetic unit 3102 and a part of of hermetic unit 3104 can have question mark shaped, reaping hook Shape or c shapes cross section.The question mark shaped, sickle -shaped or c shapes cross section can be in use by towards patient facial region Movement or flexible wider be supplied to hermetic unit 3102 and hermetic unit 3104.In the example shown, question mark Shape, sickle -shaped or c shapes cross section is set to the bottom (see Figure 71) of subgaskets 265 and/or sidewall areas 457, so Space is provided under the bottom of subgaskets 265 and in the annex of sidewall areas 457.For example, the bottom court of subgaskets 265 The outer radial skew of sidewall areas 457.Set it should be appreciated that can be formed in sealing around the whole periphery of structure 3100 Put this cross section or set this transversal (such as only in upper lip area 255) only in the selection area of sealing structure 3100 Face.Moreover, the size and/or construction of this cross section can change in selected region.

In the Figure 73 and Figure 74 example shown, D6 is about 40mm to 50mm (such as about 42mm), and D7 is about 55mm to 75mm (such as about 68mm), and D8 is about 20mm to 30mm (such as about 24mm).Although there is provided specific Size, but it is to be understood that it is that these sizes are merely exemplary and based on application other sizes be possible.For example, being based on Using exemplary dimensions can change almost +/- 10% to 20% (see Figure 75).

Sealing area 251

Reference picture 73, according to another form of this technology, sealing, which forms structure 3100, includes sealing area 251.Sealing Region 251 may be adapted to seal with the interface of patient 1000 and with patient airway formation.Sealing area 251 can include the bridge of the nose Region 252, nose lateral side regions 253, naricorn region 254 and upper lip area 255.Sealing area 251 can include barrier film or thin Piece type seal 260.In an example, barrier film 260-1 inward flange can include pearl part 260-1, such as to prevent from tearing Split, strengthen the sealing along edge.Sealing area 251 may further include on the part of sealing area 251 or whole periphery Around the end liner mat structure that extends or support band 265.The further scheme of this technology is formed for the sealing for mask 3000 The wing of nose or flaring nare of patient is sealed and crossed at structure 3100, the upper extent of its nasal area above usually nose Open portion's extension.

In an example, sealing area 251 can with it is pre-formed or otherwise preform with to meet that trouble The facial pattern of person.

Along the sealing of the bridge of the nose

One scheme of this technology is related to the sealing of the sealing area 251 in nasal bridge region 252.In an example, nose Sealing area 251 in beam region 252 is suitable for along the bridge of the nose between the pn and the nasion of patient, and along the bridge of the nose Nasal cartilages region and under nasal bone or lower section engagement.That is, patient interface 3000, which is configured with sealing, forms knot Structure 3100, its substantially at least a portion of the cartilage skeleton of patient nose and not on nasal bone, i.e., along the bridge of the nose and It is not in contact with the skin seal of the bridge of the nose/on nasal bone.

For example, sealing area 251 is suitable for positioning and is sealed in the nose generally above nose (i.e. above pn) Its upper extent in region, and cross patient the wing of nose or the flaring nare portion of opening extension, such as not above the nasal bone of patient or Extend not across the nasal bone of patient.

In an example, sealing area 251, which is positioned at, is generally proximal to have some more nosey bones and cartilage Between abutment nasal area in play upper extent, and avoid influence from being regarded with the patient 1000 compared with spur Line.

Nasal bridge region 252

Reference picture 74, nasal bridge region 252 may adapt to engage with the bridge of the nose of patient 1000.In an example, the bridge of the nose Region 252 can shape or the pre-formed bridge of the nose to adapt to patient, and nasal bridge region 252 can be lower than the side of nasal area 253 (that is, closer to attachment area 158).Nasal bridge region 252 can be included in no subgaskets or be used in the case of supporting band close The barrier film 260-1 of envelope.In an example, this arrangement avoids the excess pressure in sensitive nasal bridge region 252.In a reality In example, the barrier film 260-1 at nasal bridge region 252 can be with other regions of the sealing area 251 of ratio such as upper lip area 255 Barrier film 260-1 it is relatively longer.The length of barrier film 260-1 in nasal bridge region 252 can be such as 2mm to 5mm.In a reality In example, the length of the barrier film 260-1 in nasal bridge region 252 can be about 2mm to 4mm.In an example, nasal bridge region The length of barrier film 260-1 in 252 can be about 3mm.

Nose lateral side regions 253

Reference picture 74, nose lateral side regions 253 may adapt to the engagement sides with patient nose.In an example, nose Lateral side regions 253 can with it is pre-formed for adapt to patient nose side and be possible to adapt to their cheek.Nose lateral side regions 253 summits for forming structure 3100 from sealing at nasal bridge region 252 extend to naricorn region 254.Nose lateral side regions 253 are from nose Beam region 252 is inclined upward to naricorn region 254.Nose lateral side regions 253 can be included in without subgaskets or support the feelings of band It is used for sealed barrier film 260-1 under condition.In an example, this set prevents patient's nasal side face or the wing of nose or flaring nare from opening in portion Excess pressure.Excess pressure on these regions can cause nose flexible pipe inwardly to be collapsed towards nasal septum, so as to block or partly Block the air flue of patient.

Naricorn region 254

Reference picture 74, naricorn region 254 may adapt to seal with the formation of patient's naricorn.Naricorn region 254 has conduct The summit or tip of the maximum height of sealing area 251.This height ensures maximum power being applied in naricorn region 254 Sealing area 251, because the sealing area 251 in the naricorn region 254 is the region of facial boniness, and therefore to pressure Power susceptibility is relatively low.Moreover, because the geometric figure in this region of patient facial region is considerably complicated, patient facial region this Individual region is especially difficult to seal, therefore the power in the sealing being applied in this region is bigger, more may form sealing.Separately Outside, because requiring less sealing force (in order to comfortable and avoid occlusion) in nasal bridge region 252 and nose lateral side regions 253, So sealing area 251 must be anchored at naricorn region 254.Naricorn region 254 can include barrier film or diaphragm seal 260 And end liner mat structure or support band 265.Both barrier film 260-1 and end liner mat structure 265 use can ensure nose region 254 In bigger sealing force.In an example, barrier film 260-1 can have about 0.1-0.5mm thickness, for example about 0.3mm.In an example, end liner mat structure 265 can have about 0.3mm to 2mm thickness.

Upper lip area 255

Reference picture 74, the surface that upper lip area 255 may adapt between patient's upper lip and nose bottom is engaged.In a reality In example, upper lip area 255 can have the diaphragm length more relatively much shorter than nasal bridge region 252, and such as about 0.5mm is to about 2.5mm length, such as about 1.5mm to 2.5mm.In an example, this shorter diaphragm length is as some patients There is advantage when only there is small space between their upper lip and their nose bottom.Upper lip area 255 can have barrier film close Sealing 260 and end liner mat structure support band 265.On both barrier film 260-1 and end liner mat structure 265 use can ensure Bigger sealing force in lip region 255.In an example, barrier film 260-1 can have about 0.1-0.5mm thickness, Such as 0.3mm.In an example, end liner mat structure 265 can have about 0.3mm to 2mm thickness, for example about 1.5mm.In an example, the thickness of end liner mat structure 265 can change along the length of upper lip area 265, such as from nose The about 1.2mm of about 0.3mm at angular zone 254 to the centre of upper lip area 255.

Seal

If end liner mat structure 265 supports the use of band to enable to barrier film 260-1 or face plate single with only using The situation of individual non-supported thin slice is significantly thin compared to manufacture.This is considerably advantageous, and reason is thinner thin slice then more It is flexible, to feel scrambling that is more soft and more comfortable and more easily conforming to face contour.This also allows thin slice More readily respond in acting on the system pressure in the pumping chamber 3200 on the bottom surface of pumping chamber 3200, to promote the thin slice to enter Enter and combined with the tight seal of patient facial region.

As noted, patient interface is configured with the cartilage skeleton substantially on nose (i.e. not in nose On bone) and the sealing forming region that does not stop nose.In an example, by providing along patient's upper lip (such as under Hermetic unit 3104) and compression seal (for example, using end liner mat structure 265) not on the nose of patient can realize This sealing forming region.Sealing on patient nose can be realized by the tension force and/or pneumostop in barrier film 260-1 (for example, top sealed portion 3102).

In an example, end liner mat structure or support band 265 are provided only on the naricorn region that sealing forms structure 3100 254 and upper lip area 255 in.That is, sealing area 251 includes only constructing in nasal bridge region 252 and nose lateral side regions Single-layer septum 260-1 in 253, and sealing area 251 includes the two-layer separator in upper lip area 255 and naricorn region 254 260-1 and end liner mat structure 265.Double-decker provides the compression seal along upper lip area 255 and naricorn region 254.Phase Instead, nasal bridge region 252 and nose lateral side regions 253 use the tension force in barrier film 260-1 (due to being applied to barrier film 260-1 tension force And barrier film 260-1 edge is stretched in sealing engagement) and/or pumping chamber 3200 in the pressure acted on barrier film 260-1 Power (pneumostop) is to provide sealing.Individual layer be additionally arranged in nasal bridge region 252 and nose lateral side regions 253 with provide avoid it is any The more soft and more flexible seal of patient nose may be stopped, that is, prevent from opening in portion in patient nose side or the wing of nose or flaring nare Meeting cause cartilage inwardly to cave in and be likely to make at least in part the excess pressure of patient airway occlusion.

Therefore, formed according to the spacer assembly 3002 of this technology example in sealing in the different piece of structure 3100 Different sealing mechanism is provided.For example, spacer assembly 3002 can provide a kind of in the upper section that sealing forms structure 3100 Sealing mechanism (for example, sealing and/or pneumostop by the tension force in barrier film 260-1) and form structure 3100 in sealing Relatively lower part in provide different sealing mechanism (for example, compression seal).In the example shown, spacer assembly 3002 provides warp By the compression seal of double-deck or barrier film 260-1 and end liner mat structure 265.It will be appreciated, however, that for example, by gel-filled or Foam-filled capsule, the alternative structure of thicker single wall (such as silicones thick about 0.8mm to 1.2mm) can be provided Compression seal.

When the face of spacer assembly 3002 and patient engages and are in use under pressure or the when of expansion, that is, applying Air, hermetic unit 3102, the width or contact area of hermetic unit 3104 are supplied under the normal pressure for being added to spacer assembly 3002 280 engage with the face of patient in use.Width or contact area include the inward flange for example along the edge of throttle orifice 275 280 (i) (see Figure 73) and outward flange 280 (o).Shape for example based on the nose using top sealed portion 3102, upper sealing The relatively narrow width of part 3102 can engage to form sealing with the bridge of the nose.The relatively broad part of top sealed portion 3102 Sealing can be formed with the skin engagement of adjacent side nasal cartilages.In sealing portion point 3104, substantially sealing portion is divided 3104 whole width can form sealing along naricorn region 254 and upper lip area 255 and skin engagement.Therefore, make Hermetic unit 3102, the width of hermetic unit 3104 or the contact area engaged in patient facial region can be in spacer assembly Change to form sealing around 3002 peripheries.

Sealing sheet

In an example, as shown in Figure 73 and Figure 74, each nose lateral side regions 253 of sealing area 251 include The part 270 of the such as wing or sealing sheet that are protruded along barrier film 260-1 interior periphery from barrier film 260-1 edge.Each Sealing sheet 270 is adapted to connecing between the greater alar cartilage of patient nose and outer lamina dorsi nasi (also known as wing of nose wrinkle) Sealing is formed on the adjacent region of chalaza.Accurate location of the sealing sheet 270 on face in use can be based on using being somebody's turn to do The size and dimension of the nose of sealing sheet and change.

As shown, each sealing sheet 270 is outwardly away from the pumping chamber that sealing forms structure 3100 at least in part 3200 and form angle or prebias.When sealing sheet 270 is engaged with the nose of patient, sealing sheet 270 is towards pumping chamber 3200 deflections, the sealed biasing provided in abutment mentioned above.That is, the shape of sealing sheet 270, Pliability and prebias allow thin slice 270 adapt to the curvature in this abutment or profile change (for example, this when the wing of nose or Tend to continuous change when " flaring nare opens portion " is in use), so that maintenance seals and prevents leakage in use.

Reference picture 73 and 74, in an example, sealing flange 3110 (including barrier film 260-1 and sealing sheet 270) limit Fixed generally T-shaped throttle orifice.The barrier film 260-1 edge along its inner circumference is together with each sealing sheet 270 along its inner circumferential The edge on side coordinates together is limited to throttle orifice 275 in pumping chamber 3200.In an example, this throttle orifice 275 is It is generally T-shaped, including upper Orifice portion 275 (1) is (along the vertical axes v) as seen in Figure 73 and being typically normal to upper section Orifice portion 275 (1) and extend lower Orifice portion 275 (2) (along the trunnion axis h) as seen in Figure 73.

The sealing sheet 270 of nose lateral side regions 253 changes the curvature and/or angle at the edge for limiting throttle orifice 275, that is, saves The edge of discharge orifice 275 upwards or is outwardly away from pumping chamber 3200 and bent at least along sealing sheet 270.

The curvature of pad

The curvature that sealing forms structure 3100 can be along the barrier film formed in sealing in the different zones in structure 3100 260-1 patient contact surfaces change, such as to contribute to the sealing in the facial different zones of patient.

For example, as shown in Figure 73, nasal bridge region 252 and upper lip area 255 each include in curvature being local At least a portion of saddle shape, for example, be bent upwards and be bent downwardly in the other directions in one direction.Should Understand that curvature shapes mentioned above are approximate shapes and should not restricted to the definition on the strict mathematical of this shape.Separately Outside, it should be understood that region can include approximate curvature shapes, but the magnitude of this curvature can be different.For example, nose Both beam region 255 and upper lip area 255 can be included at least a portion of local saddle shape, but each region In, the magnitude of the curvature on one and/or two basic direction of this saddle shape can be different.

Hole

In an example, in the case where single mask should be used to adapt to about 85% female population, end liner Pad holes width (for example, being shown in Figure 76 with uw) be about 36mm to about 42mm, or about 38mm to 40mm.At one In example, in the case of the male demographic that should be used to adapting to about 85% in single mask, subgaskets hole width is about 40mm is to about 46mm, or about 42mm to about 44mm.In one form, in order to not agnate nasal width change phase Symbol, in order to adapt to up to 95% average population, subgaskets hole width be about 50mm to about 56mm, or about 52mm is extremely About 54mm.

In an example, in the case where single mask should be used to adapt to about 85% female population, barrier film Hole width (for example, being shown in Figure 76 with mw) be about 23mm to about 29mm, or about 25mm to about 27mm.One In individual example, in the case of the male demographic that should be used to adapting to about 85% in single mask, barrier film hole width is about 39mm is to about 45mm, or about 41mm to about 43mm.In one form, in order to not agnate nasal width change phase Symbol, in order to adapt to up to 95% average population, subgaskets hole width be about 49mm to about 55mm, or about 51mm is extremely About 53mm.

Sidewall areas 457

Reference picture 71, sidewall areas 457 can be between the sealing area 251 and attachment area 158 of spacer assembly 3002 Extension.Sidewall areas 457 can be typically cone, that is to say, that the sidewall areas 457 can have closest to attachment regions The first diameter at domain 158 and the Second bobbin diameter closest to sealing area 251, wherein the first diameter is less than Second bobbin diameter.Side Wall region 457 can have about 1.5-5mm thickness, such as about 1.5-3mm, about such as 2mm.This thickness can be with Some supports to sealing area 251 are provided to form structure 3100 to ensure to seal when in use and will not collapse because of headband tension force Collapse.

Thinner walls section

Reference picture 71, the sidewall areas 457 between sealing area 251 and attachment area 158 includes and sealing area 251 The adjacent region in upper lip area 255, the region is included near the bridge of the nose than sealing area 251, nasal side face and naricorn region The small thickness of correspondence thickness.That is, the region is transversal including the thin-walled adjacent with the upper lip area 255 of sealing area 251 Face.The power that the region of this thinner cross section makes the section along upper lip area 255 be provided by sealing area 251 is reduced.For example, This region is provided (that is, compares upper lip along upper lip area 255, smaller than naricorn region 254 pressure along naricorn region 254 Region 255 is harder, so as to cause or influence the relatively bigger pressure along naricorn region 254 (along the lip adjacent with the wing of nose Angle)), so as to the excess pressure on the nose pillar or nasal septum of the patient nose that avoids the more sensitive area as patient nose.

Figure 74 depicts nasal bridge region 252 and upper lip area 255, display only construct individual layer in nasal bridge region 252 or Barrier film 260-1, and bilayer or barrier film 260-1 and end liner mat structure 265 in upper lip area 255.For example, with labial region,superior Thinner transverse cross-sectional area in the adjacent sidewall areas 457 in domain 255 avoids the excess pressure on nose pillar or nasal septum.

6.3.2 pumping chamber 3200

It is used as allowing the nostril of patient and via short according to the pumping chamber 3200 of a form of scheme of this technology Air-flow between the supply of the air from PAP equipment 4000 of conduit 4180.In this approach, pumping chamber 3200 be able to can be replaced Selection of land is used as the inlet manifold during the air-breathing part of respiratory cycle, and/or going out during the expiration part of respiratory cycle Mouth manifold.

Pumping chamber 3200 includes holding structure 3242 and supercharging join domain 3240.

Partial pumping chamber 3200 is formed by side wall.In one form, side wall includes the sidewall areas of sealing area 251 457.Pumping chamber 3200 has the periphery 3210 for the facial surface profile for being configured to conform generally to ordinary people (see Figure 73 to figure 76).In use, the margin 3220 of pumping chamber 3200 orientates the adjacent surface for being very close to patient facial region as (see Figure 80 And Figure 81).Actual contact with patient facial region is formed structure 3100 and provided by sealing.In an example, sealing forms structure The 3100 whole periphery 3210 in use on pumping chamber 3200 extends.In an example, pumping chamber 3200 is suitable for connecing Packet receiving includes a part for the nose of the patient of pn, cartilage skeleton of such as pumping chamber 3200 in the nose including pn In a part or surrounding formed.

In an example, the wall of pumping chamber 3200 is flexible or semirigid.In an example, pumping chamber 3200 do not include rigid frame or shell.In an example, the wall of pumping chamber 3200 is nonrigid, and such as pumping chamber 3200 wall is non-soft.In particular form, the pliability of the wall of pumping chamber 3200 helps to remove conduit drag force In order to avoid upset sealing.

In one form, the wall of pumping chamber 3200 is molded by silicone rubber.In an example, pumping chamber 3200 wall is by A type identation hardnesses with about 35 to about 40 and with about 2mm to about 4mm scopes thickness The silicone rubber construction of degree is formed.In the particular form of this technology, pumping chamber 3200 has different thickness in different regions Degree.

Pumping chamber 3200 can be formed by thermoplastic construction.

According to this form of another scheme, pumping chamber 3200 provides sealing and forms structure 3100 with positioning and stably Padding function between structure 3300.

But, in a kind of form of pumping chamber 3200, performed by identical physical unit inlet/outlet manifold and Padding function, in the alternative form of this technology, they are formed by two or more parts.

Sealing, which forms structure 3100 and pumping chamber 3200, can for example be molded and be formed as single and unified part.

The formation of margin 3220 of pumping chamber 3200 forms the connection of structure 3100 with sealing.Margin 3220 can To be formed by the silicone rubber for example with the A type identation hardnesses in the range of about 35 to about 45.If however, phase The thickness of ground regulation margin 3220 is answered to obtain similar power level, then broader scope is possible.

In one form, pumping chamber 3200 may further include sealing lip 3250 (see Figure 80).Sealing lip 3250 can To be constructed by the flexible elasticity material of the silicone rubber for example with the A type hardness testers in the range of about 30 to about 50 Into to form relatively soft part.Sealing lip 3250 can be located on the inner surface of pumping chamber 3200 or inner rim or be located at On the whole inner rim region of pumping chamber 3200 or be formed as the inner surface of pumping chamber 3200 or a part for inner rim or formation For the part in the whole inner rim region of pumping chamber 3200.But, should be contemplated to sealing lip 3250 can be arranged on supercharging Around the outer surface or neighboring of room 3200, or around the whole neighboring of pumping chamber 3200.Sealing lip 3250 can form increasing Pneumostop between pressure chamber 3200 and framework 3310, as will be described in more detail.Sealing lip 3250 and pumping chamber 3200 can also include integral piece.

Other patient interface devices formation pumping chamber and using compression seal framework between pneumostop, with compress by The pumping chamber that the elastic deformation material of such as silicones is made, thus by pumping chamber's bonded to frame while formed it is pneumatic Sealing.On the contrary, a kind of example of this technology, when by hindering sealing lip 3250 to be deflected against framework 3310 by pumping chamber 3200 when being initially fixed to framework 3310, forms pneumostop.When the pressure in pumping chamber 3200 increases to more than air pressure For treatment respiratory disorder when, pneumostop enhancing and sealing force increase because using opposing frame 3310 more energetically To promote sealing lip 3250.The air formed in the sealing of these other patient interface devices in the pumping chamber 3200 of structure 3100/ Pressure does not influence to seal the sealing force to be formed between structure 3100 and framework 3310.Moreover, these other patient interface device tools Have with the soft pad of side wall for being used to engage with framework and sealing lip, because they are easy to meet finger pressure and it is soft , be nonrigid and it is less laborious just can elastic stretching or bending.Specifically, due to the size and length-width ratio of nose pad Relatively large, this contributes to the flexibility of pad.The side wall engaged for framework is so soft, to cause the relative side of pad It can just shrink together and contact with each other using minimum finger power.This easy side wall for framework engagement becomes Shape can be difficult to pad quick connecting to framework in other patient interfaces for the scorching patient of hand joint Main source.It should be understood that by forming the feature of pumping chamber 3200 above-described, with enough rigidity, can improve by Sealing forms the sealed stability of structure generation.Furthermore, it is possible to change the thickness of pumping chamber 3200 so that thickness connects from supercharging Connecing region 3240 to sealing and forming structure 3100 becomes thinner.In an example of this technology, pumping chamber 3200 connects in supercharging Connect region 3240 nearby or be pressurized thickness about 2mm to 3mm at join domain 3240, in supercharging join domain 3240 and sealing shape Thickness is 1mm at into the point between structure 3100, and is formed near structure 3100 in sealing or forming structure in sealing Thickness is 0.75mm at 3100.Form the pumping chamber 3200 with these features casting can manufacture to complete again.Supercharging The silicon tree caused closer to hermetic unit 3102, the contact area of hermetic unit 3104 is gradually decreased on the thickness of room 3200 The deformation of fat material is bigger, so as to strengthen patient comfort and reduce the possibility of sealing interference.

Some nose patient interfaces have following assembling sequence：(i) pumping chamber, (ii) headband connection, (iii) sealing is formed Structure.On the contrary, an example of the patient interface 3000 of this technology possesses following assembling sequence：(i) headband is connected, (ii) supercharging Room, (iii) sealing forms structure.Difference in this set, which means that headband tension force will not cause, to cause sealing force to be interrupted Pumping chamber 3200 and sealing form the deformation of structure 3100.

6.3.3 framework 3310

Framework 3310 can be by manufacturing including Eastman Chemical (Eastman Chemical Company) Tritan^TM, the Grilamid manufactured by EMS-Chemie AG^TM, or Arkema Inc. (Arkema, Inc) manufacture Rilsan^TMG170 thermoplastic is made.Preferably, colourless clean transparent thermoplastic is used for framework 3310, and It is not translucent or opaque material.This be set to patient 1000 sight that is not blocked from is provided and it is inconspicuous and for Transparent framework 3310 now of stability for patient interface 3000.

In an example of this technology, framework 3310 can be formed by polypropylene.In other examples, framework 3310 can Formed by Fypro or polyester fiber.Framework 3310 is overmolded onto on tubulature sheathed catheter 10610, while rotating body end 4190 are joined to tubulature 4180 by press-fit via obstruction.The flexible and extendible feature of tubulature 4180 with 360 ° Rotary body extremity piece 4190 be designed as together by mask 3000 from the additional gas delivery conduit 4178 of air loop 4170 it is mechanical Separation.

In another example of this technology, as described in this article, a kind of size can be made in framework 3310, still Public sizing connection features, which are attached, to be formed structure 3100 to the pumping chamber 3200 of single framework 3310 and sealing and can make Into multiple sizes.In an example, sealing is formed structure and three sizes can be made but are attached using identical to frame The holding structure of frame.It is to be understood, however, that it is possible that sealing, which forms the more or less size of structure,.

In an example of this technology, framework 3310 can be molded in the case of not any undercutting so that It can be moulded and then remove it from being molded to move tool up in the case of no bending.

Reference picture 59 is to Figure 63, in another example of this technology, and the sealing of patient interface 3000 forms part 3100 Sealing station is maintained at via the four point attachment to positioning and rock-steady structure 3300.Framework 3310 provides two pairs of opposing arms：Two Upper arm 10320 and two underarms 10330.Two upper arm provide a pair of relative upper headband tie points 10325.Underarm 10330 is carried For a pair of relative lower headband tie points 10331.In one form, lower headband tie point 10331 has and underarm 10,330 1 The cylinder form of body formation.

As shown, framework 3310 includes：Main body, it is the ring or annulus for limiting connectivity port 3600 10315 form；And fastener or bonding part 10316, from ring 10315 at its upper position in ring 10315 Extend back and (for example see Figure 59-Figure 61).Underarm 10330 is from the underarm tie point being radially positioned in ring 10315 10317 extend.In the far-end of fastener 10316, from upper arm tie point 10305, (also known as top frame is connected upper arm 10320 Point) extend so that underarm tie point 10317 is in the forward position of upper arm tie point 10305.

In an example, as best shown in Figure 60, upper arm tie point 10305 is in the most upper of ring 10315 The position in portion, and underarm tie point 10317 is orientated as with upper arm tie point 10305 into about 80 ° to about 160 °, for example about 90°。

In an example, upper arm 10320 and their upper headband tie point 10325 are positioned and are orientated so that they Power/the tension force provided by top counterband tape 10230 is directed to upward force vector.Upward force vector provides power to allow patient to connect The sealing of mouth 3000 forms structure 3100 and is most preferably sealed in upper lip and cartilage skeleton.Top counterband tape 10230 is by framework Upward force vector on the 3310 top pilot seal region 251 in the way of this power to be transformed into sealing form structure 3100 Top nasal bridge region 252.Upper arm 10320 is overarched or bent towards from the upwardly direction of top frame tie point 10305.

In an example, underarm 10330 and their lower headband tie point 10331 are positioned and are orientated so that it Following counterband tape 10220 is oriented to downward force vector, it provides the reaction force that contracts upwards of resistance nose cup 3000 and offer Any sealing destruction power in upward direction is so as to increase stability.Reaction force can also provide downward force vector, this Sample increases the stability of the conduit top configuration of the tubulature 4180 of patient interface 3000 in use.

As noted, upper arm tie point 10305 and underarm tie point 10317 are spaced a predetermined distance from, i.e., upper arm connects Contact 10305 is arranged on after underarm tie point 10317 or rear portion, and this provides framework 3310 most relative to the face of patient Big slant range.This skew spacing limits the arm of force MA for providing maximum inclination scope (see Figure 111).This skew spacing is by connecing Being there is provided using part for part 10316 is provided.

Figure 111 be shown between upper arm tie point 10305 and underarm tie point 10317 on the rotation in framework underside Center or pivoting point PP arm of force MA.In an example, the face that structure 3100 was attached or contacted patient is formed with working as sealing When it is shown compare, pivoting point PP can be less than and/or closer to the face of patient.Because the upper arm on framework 3310 connects The single and center of contact 10305, rotation pivot point/pivot PP of framework is facial to lower relative to patient Place's movement.This produces inclination when top counterband tape 10230 is conditioned/fastened, to ensure that patient interface 3000 is adapted to well In patient.Facial and desired cooperation based on patient, framework 3310 separates upper arm 10320 from underarm 10330, on making Band 10230 can have the differential tension to lower band 10220.

Top counterband tape 10230 is connected to framework 3310 via upper arm 10320 at single central upper point 10305, because This is when applying headband tension force, and upper headband vector UV is arranged essentially parallel to Frankfurt plane direction.This minimize mask 3000 upper contracting or lower contracting, and form good stability.That is, upper arm 10320 and top counterband tape 10230 It is separably engaged, and the tension force vector of top counterband tape 10230 is oriented to and Frankfort horizontal direction base by upper arm 10320 In parallel direction and avoid crossing patient's ear and extending in sheet.In an example, when answering headband tension force, underarm 10330 provide the lower headband vector LV for being arranged essentially parallel to Frankfort horizontal direction.

Figure 111 shows maximum inclination ranges scheme and the maximum inclination scope and headband power or the relation of tension force vector. When top counterband tape 10230 is fastened, top counterband tape 10230 can pull upper arm 10320 and patient interface 3000 is inclined Tiltedly and preferably coordinate and/or seal so that the cross section on the preceding surface of framework 3310 is substantially perpendicular to Frankfort water Square to.This can prevent facial and upper contracting or lower contracting of the mask 3000 relative to patient.

Moreover, in an example, upper arm 10320 includes enough stiff/rigids, so as to from top counterband tape 10230 headband tension force does not cause the shape or profile that substantially deform or change upper arm of upper arm 10320.For example, upper arm 10320 It is sufficiently rigid or hard enough with the rotation relative to framework 3310 and prevent that upper arm 10320 is straight when applying headband tension force Or flatten.On the contrary, the power from the headband tension force fastened to top counterband tape 10230 is transformed into upper arm tie point 10305, so that the ring 10315 of framework 3310 is tilted on rotation pivot point as noted above/pivot PP, so as to Spacer assembly 3002 provides optimal sealing.

WO2009/108995 discloses a kind of mask system example, and the mask system, which includes carrying, is provided with upper and lower headband The upper arm of connector and the covering of underarm.Framework 3310 with an example according to this technology is on the contrary, WO2009/ Rotation in 108995/inclined be centrally located at in the identical hat plane of upper headband tie point and lower headband tie point, i.e., WO2009/108995 does not offset upper headband tie point and lower headband tie point.That is, according to the framework 3310 of this technology Rotation/inclination the center not being located at in upper headband tie point and lower headband tie point identical hat plane is provided.Moreover, root Nasal interface or nasal mask are provided according to the patient interface 3000 of the example of this technology, it provides ratio such as in WO2009/108995 Disclosed in the smaller facial space-consuming of foil facial mask, and provide different vector sums when adjusting headband tension force and incline Tiltedly.

A single point (i.e. such as upper arm tie point 10305) place by upper arm 10320 be bonded to ring 10315, in ring Fastener 10316 on 10315 is relatively rigid, so that power is substantially completely converted and sufficiently tight, to prevent in engagement Breakage at part 10316.Can be by structural detail (reinforcing ribs) or material properties (thicker or harder material) or both Engage to realize stiffness.

In an example of this technology, the upper arm 10320 of framework 3310 is symmetrical.Upper arm 10320 connects in top frame Extend at contact 10305 from framework 3310 and the centre position between the eyes and ear of patient is substantially terminated.Make In, upper arm 10320 extends on the cheek of patient and the profile with bending is to coordinate the facial profile of patient, so that Obstacle is obtained to minimize.Upper arm 10320 extends outward to make between upper arm 10320 and the face of patient from the face of patient Contact minimizes uncomfortable to avoid.In further example, top frame tie point 10305 of the upper arm 10320 from framework 3310 Extend 80mm between 100mm.

Underarm 10330 is in the direction of the second bending sections 10311 of the upper arm 10320 being approximately parallel in transverse plane Extended outward (see Figure 62 and Figure 63) from framework 3310 with an angle.Underarm 10330 has some curvature in sagittal plane, and And curvature direction is in downward direction.Underarm 10330 has crooked outline to coordinate the face of patient in use, to make barrier Hinder and minimize and close consistent with the face of patient.

The length of underarm 10330 is approximately the half of the length of upper arm 10320.Underarm 10330 in use extends to base Point in sheet on the bottom of patient's cheek.In further example, underarm 10330 is from the coupling part 3600 of framework 3310 Bottom extends 20mm between 40mm.

6.3.3.1 the shape of the arm of framework 3310

Reference picture 56- Figure 61, since top frame tie point 10305, upper arm 10320 enters approximate tracking connectivity port In the downward arch direction of 3600 curvature.The stretching space 10306 extended from framework 3310 is by upper arm 10320 and underarm 10330 separate.This separates upper arm 10320 from underarm 10330, and therefore four arms 10320,10330 of framework 3310 In each of should minimally influence other arms 10320,10330.On the contrary, the arm-piece of Y shape or bifurcated is generally easy to pair Upper headband point is converted to mobile between lower headband point.

Each upper arm 10320 has the first bending sections that the first bending 10308 is extended to from top frame tie point 10305 10307.Wheel on the profile curves of the inner surface of first bending sections 10307 to the outer surface for corresponding to spacer assembly 3002 It is wide.The top edge of the feather edge of first bending sections 10307 and the outer longitudinal edges one-level underarm 10330 of connectivity port 3600 Limit the space 10306 elongated.Substantially straightforward face 10309 extends to the second bending 10310 from the first bending 10308.

Second bending sections 10331 extend up to the distal end of upper arm 10320 since the second bending section 10310.Second is curved The curvature direction in bent section 10331 is in upward direction.Second bending sections 10331 of upper arm 10320 provide extra support And rigidity.Second bending sections 10322 are extended to sharp or smoothly transitted on width towards upper headband tie point 10325, with Form the thinner distal end 10323 of upper arm 10320.

The distal end 10323 of upper arm 10320 is the enlarged of upper arm 10320, and upper arm has with the slit 10325 of elongation The upper headband tie point 10325 of form is to receive top counterband tape 10230.Distally 10323 is upward with the second bending sections 10311 It is angled, so that upper headband tie point 10325 is positioned substantially between the eyes of patient 1000 and ear in use.Make In, the inner surface profile of distal end 10323 meets the in upper cheek region of patient and substantially between eyes and ear Face contour.The longitudinal axis of the slit 10325 of elongation is orientated axis oriented normal substantially with upper arm 10320 (for example, such as Seen in Figure 61, the longitudinal axis of slit 10325 is substantially perpendicular to the longitudinal axis of the second bending sections 10311 of upper arm 10320) And it is designed and sized to receive the top counterband tape 10230 passed through.

Because upper arm 10320 has 3D shape and is nonplanar, upper arm 10320 has sagittal plane, coronal Curvature in face and cross section.The shape of upper arm 10320 is intended to follow the cheek of patient, frames the face of patient and patient's Outside sight.In summary, the profile of upper arm 10320 shows that the inner surface in straightforward face 10309 is bending so that inner surface exists Meet the curvature close to cheek region of patient facial region in use (see Figure 58).In addition, upper arm 10320 is bending and mutual Separate multiple sizes of the spacer assembly 3002 to adapt to separably be attached to framework 3310.For example, the first of upper arm 10320 Bending sections 10307 can separate another preset distance to adapt to the wide size range of spacer assembly 3002.

The shape of the curve of upper arm 10320 is intended to the cheek immediately following patient.During use with the cheek contacts of patient The relative position of upper arm 10320 is so that upper arm 10320 is not slided on the face of patient.For example, upper arm 10320 can be gently Ground is located under the cheekbone of patient, prevents the upward sliding of upper arm 10320.Moreover, in the largely or entirely interior table of upper arm 10320 Contact between the face of face and patient can increase frictional force to prevent sliding stop and finally minimize upset to sealing force. The shape of the crooked outline of upper arm 10320 will be positioned and rock-steady structure 3300 be oriented to eyes in most people's bulk measurement scope and Between ear.This orientation is helpful, because this is attractive in appearance and from patient 1000 and patient bed companion 1100 As viewed from the perspective of be accessible.

6.3.3.2 the pliability of the arm of framework 3310

Relative to arm 10320 and/or framework 3310 in specific direction of the upper arm 10320 on the ad-hoc location along upper arm It is more flexible.By the upper arm 10320 more flexible when the displacement in specific direction, to patient 1000 more provide it is comfortable Degree, the smaller possibility that the sealing as caused by conduit torque is interrupted, and therefore cause increase to be held according to frequency of use and therapy The degree of deferring to of patient between renewing to therapy.In an example, upper arm 10320 is more flexible than underarm 10330.Counterband tape right overhead 10230,10220 when being fastened, and arm 10320,10330 is not stretched.

The relative flexibility of upper arm 10320 in different directions is also important Consideration.For example, upper arm 10320 May be more flexible to adapt to different trouble than in other planes in sagittal plane (such as side outward direction) as shown in Figure 60 The facial width of person.If the pliability in the cross section (for example, vertically downward direction) shown in such as Figure 60 (is equal to greatly very much Side outward direction), then it there may be sealing unstable.In an example, upper arm 10320 compares on laterally outwardly direction It is more flexible in vertical downward direction.Upper arm 10320 is more flexible by 9 to 10 than in vertical downward direction on laterally outwardly direction Times.Preferably, upper arm 10320 on laterally outwardly direction flexible 9.23 times than in vertical downward direction.Conduit torque may be used also To be handled in the connection with other mask parts, such as tubulature 4180 (for example makes its lighter weight, more attractive or more Flexible) or use, ball-and-socket joint or the armour shape of rotary connector or corrugation section.But, the facial width of change is main Determined by the pliability of upper arm 10320, and therefore, upper arm 10320 need to compare on laterally outwardly direction with vertically to Lower section has more pliability upwards.

The middle section 10313 of underarm 10330 is narrower than the distal end of underarm 10330 (see Figure 60).This narrower central area Domain 10313 is that underarm 10330 provides some pliabilities, in order to be bent in sagittal plane.Underarm 10330 is with it in sagittal plane Pliability compared to being substantially not flexible or unlike so flexible in coronal-plane and cross section.Control underarm 10330 Pliability cause mask 3000 more stable and comfortable for patient 1000.By using adjustable shackle bindiny mechanism 950 adjust the length of headband band 10230,10220 with fastener head counterband tape 10230,10220.Because headband folder 10210 Machinery retain part 10215 engagement underarm 10330 lower headband tie point 10331 and reversely pulling lower headband tie point 10331, so the regulation of the length of correct counterband tape 10220 can cause underarm 10330 towards the slight bending of patient 1000.

Some rigid head-wearing parts of existing mask are harder than framework.Typically, these rigid head-wearing parts use screw thread Arm and bolt coordinate the head of patient to adjust headband manually.Although flexible frame can improve mask comfort level, there is provided good Sealing, minimize the leakage caused by carelessness and cause headband for the lower pressure level for the treatment of too tight risk Minimize, but if requiring that flexible frame forms structure with sealing and separably dismantled, then some can be triggered difficult.Sealing Forming structure has bullet flexible, to form structure to seal and forms sealing to patient airway.If sealing forms structure There is similar pliability (i.e. very flexible or soft) with framework, then two parts are bonded on one for patient 1000 It is difficult to rise, for particularly difficult with the scorching patient 1000 of hand joint in dim room.

Some rigid head-wearing parts of existing mask can be dismantled from framework.Typically this is by both firm It is clasped or presss from both sides the mode of connection to realize between the rigid arm and mask frame of part.Between this rigid arm and framework The connection type of hardware to hardware may cause the less pliability in tie point, it means that need more power drawing Rise and bent at the uncomfortable point for the patient for having larger face width, because may when rigid arm is under the pressure of outward bending It is subjected to convergent force.Some this rigid head-wearing parts have hard folder (hard clip) in the far-end of rigid arm, for frame The separable connection of frame.Hard folder is permanently attached to headband band, and this may destroy when the cleaning head band in washing machine and wash Clothing machine bucket or other laundry articles.And some this rigid head-wearing parts tend to requirement and have the patient interface of wider framework, This means headband band is since being spaced apart the frame position of further distance.Broader framework, which can have, is considered as frame The integrally formed side arm of a part for frame, because they are made up of same material.Patient 1000 and their bed companion 1110, which can perceive wider framework, makes obvious and does not possess expectation aesthetic property, because wider framework is covered on face Just beat region.On the contrary, in an example of this technology, upper arm 10320 is made up of poor material more flexible than headband band 3301. In other words, headband band 3301 is the most flexible part of positioning and rock-steady structure 3300, because it is main by fabric It is made.In an example, the second of positioning and rock-steady structure 3300 is flexible and the 3rd flexible part is upper arm respectively 10320, followed by underarm 10330.Most rigid or rigid part is framework 3310, especially, framework 3310 closest to connection The region of port 3600 is not easy to or not bent, stretches or bends, because this region is intended to by elastomer Deform and form sealedly sealing with patient airway and form structure 3100.The flexible difference of individual components can be controlled in spy Position the bending total amount at the place of putting and also determine when applying certain force i.e. conduit torque or accommodating bigger face width, particular portion Part starts the order of bending.The flexible difference of individual components can also start at them in a specific way or order interrupt it is close Envelope is decoupled before forming the sealing of structure 3100 to power.It is for these factor purposes for patient interface 3000 together When solve comfortableness, stability and provide excellent sealing demand.

6.3.4 the connection between pumping chamber and framework

In a kind of form of this technology, pumping chamber 3200 is removably attached to framework 3310, for example, in favor of cleaning Or various sizes of sealing is formed by structure 3100 is changed.This can allow pumping chamber 3200 can be than the He of framework 3310 Tubulature 4180 is more frequently cleaned and cleaned.Furthermore, it is possible to allow pumping chamber 3200 independently to be cleaned with headband band 3301 And cleaning.In an alternative form, pumping chamber 3200 is difficult to remove from framework 3310.

Pumping chamber 3200 can include supercharging join domain 3240 (see Figure 81).It is pressurized the holding knot of join domain 3240 The shape and/or construction of structure 3242 and the shape and/or construction of corresponding framework join domain 3312 are complementary (see Figure 83).Supercharging The holding structure 3242 of join domain 3240 is more more rigid than the other parts of pumping chamber 3200, and can by with framework 3310 Identical material is made, for example, being made up of polypropylene or polyamide.In other examples, supercharging join domain 3240 can be by Nylon is made, and framework 3310 is made up of polypropylene.Nylon, polyamide and polypropylene are not soft materials, and are difficult to adapt to Finger pressure.Therefore, when they are bonded with each other, there is audible click and hardware and hardware is connected.In Figure 83 and figure The shape of holding structure 3242 is depicted in 102-105 in the form of similar circle, parabolic cylinder or hyperbolic cylinder.Holding structure 3242 can not elongate and non-extensible, to keep its substantially shape when engaging and separated from framework 3310 with framework 3310 at it Shape.The shape of holding structure 3242 allows the bending of slight extent, but is not enough to cause the two opposite sides of holding structure 3242 to exist It can be contacted with each other when being pinched together with finger pressure.In other words, be only under normal treatment it is impossible, In the case that patient 1000 applies notable convergent force, the two opposite sides of holding structure 3242, which can be only achieved, to contact.Root According to an example of this technology, after moulding, holding structure 3242 can be bonded (for example, using adhesive) to pumping chamber On 3200.In another example, can be used between holding structure 3242 and pumping chamber 3200 full chemical key (molecule Attachment).

In an example of this technology, holding structure 3242 can be molded in the case of not any undercutting For so that it can be molded in the case of no flexure and then remove it from mould.Holding structure 3242 with frame There is continuous periphery edge on the front side that frame 3310 is contacted.This continuous periphery edge is exposed to so that itself and framework 3310 contact in the way of hardware is engaged to hardware.This is connected to form control with most software to hardware, existing at some Mask in software to hardware connect in the case of, exist covering and overlapping most of Demountable rigid holding structure sealing Form the front lip portion of structure.Front lip portion is formed by LSR and wraps up holding structure, to hold it together.However, In such existing mask, it is difficult to and troublesome is to wrap up front lip portion by detachable clip, and clip may misplace And sealing can be subsequently resulted in form structure and not can connect to framework.

One purpose of holding structure 3242 is, in its pumping chamber 3200 of being alignd when being engaged with framework 3310, because The shape (may be with different depth) of the holding structure 3242 of pumping chamber 3200 be maintained at the obstruction part 3314 of framework 3310 with In the space limited between framework join domain 3312 (Figure 97).

Another purpose of holding structure 3242 is, relatively horizontal between pumping chamber 3200 and framework 3310 by preventing To mobile and relative vertically move pumping chamber 3200 will be kept to remain to framework 3310.Supercharging join domain 3240 can include At least one keeping characteristics 3244,3245, and there may be at least one complementary framework join domain 3312,3313.Increase Pressure join domain 3240 can include one or more keeping characteristics 3244,3245 (Figure 81).Except preventing the He of pumping chamber 3200 Relatively transverse movement between framework 3310 and outside vertically moving, another purposes of keeping characteristics 3244,3245 be in order to Prevent the relative longitudinal motion between both parts.The remainder of pumping chamber 3200 can include than the He of holding structure 3242 It is pressurized the more flexible material of join domain 3240.

In one form, supercharging join domain 3240 by rigid or semirigid material (such as high rigidity silicon or TPE, Plastics, nylon, exotic material, polypropylene and/or makrolon) construction form.Be pressurized join domain 3240 can by with increasing The material construction that the other parts of pressure chamber 3200 are different is formed.For example being pressurized join domain 3240 can be and pumping chamber 3200 Permanently connected, the joined integrally or mechanical interlocked individual components in coupling part 3202 (Figure 81).Go to Figure 89, pumping chamber 3200 coupling part 3202 can have the thickness roughly the same with being pressurized the holding structure 3242 of join domain 3240.Supercharging connects Connecing region 3240 may include tongue-like part 3211, and the tongue-like part 3211 is constructed or is arranged to by (the example of channel part 3211.1 Such as the channel part of framework 3310) (Figure 92) matchingly receive.By this way, channel part 3211.1 can be formed for tongue The mating feature in shape portion 3211, vice versa.In addition, tongue-like part 3211 and channel part 3211.1 can be sized to make this Sealing surfaces area in region is maximized.

6.3.4.1.1 pumping chamber and the attachment in framework and the removal from framework

Pumping chamber 3200 can be fixedly attached to framework 3310, but it can also be removably attached to framework 3310.Figure 90 show the coupling part 3202 of the pumping chamber 3200 in the link position relative to framework 3310.In this example, it is pressurized Join domain 3240 only includes the keeping characteristics 3244 being positioned on join domain 3240.Figure 90 is shown through crook 3246 Cross section, and Figure 92 shows another cross section in the absence of crook 3246, to form such as passage or groove 3211.1.Elastic hook portion 3246 is a class buckle-type press-fit component, to provide high confining force (to prevent accidental separation), and Also enable relatively easily removal intentionally.In Figure 92, supercharging join domain 3240 and framework 3310 in glossal canal mode simply It is assembled together.Framework 3310 and holding structure 3242 may be shaped so as to be connect in keeping characteristics 3244,3245 and framework 3310 Tongue-like part 3211 is engaged with channel part 3211.1 before conjunction.This can help to the alignment of keeping characteristics 3244,3245 to be connected Connect.

It is connected to the supercharging join domain 3240 (see Figure 81) of framework 3310, including positioned at two of top and bottom (no With width) " snap features/crook " (for example, keeping characteristics 3244,3245).This enables easily unidirectionally to assemble with framework And enough confining forces are provided in use.When silicon lip seal 3250 is assembled into framework 3310, in spacer assembly Obstruction part 3314 of the silicon lip seal 3250 on framework 3310 around 3002 inner rim is deflected, as shown in Figure 90.This Kind hinder provide between spacer assembly 3002 and frame assembly 3001, under stress definitely enhanced aeroseal.Pass through Spacer assembly 3002 is shunk at two " snap features " positions (such as keeping characteristics 3244,3245) place positioned at top and bottom And pull spacer assembly 3002 away from framework 3310 and disassemble spacer assembly 3002 from frame assembly 3001.At one In example, holding structure 3242 may be constructed such that the engagement that is repeated with framework and from its repeatable separation.

Each keeping characteristics 3244,3245 can take the crook with preceding surface 3246.1 and rear surface 3246.2 3246 form (Figure 89 and Figure 90).Preceding surface 3246.1 is suitable to work as pumping chamber 3200 and framework 3310 is moved into connects each other During conjunction, engaged with the introducing surface 3312.1 of the framework join domain 3312 of framework 3310.When keeping characteristics 3244 are pushed into just Deformed during position, as shown in Figure 95 and Figure 96.In addition, the framework join domain 3312 of framework 3310 and hinder part 3314 it is upper Portion region and lower area may also be slightly distorted.In addition, holding structure 3242 can also be slightly distorted, particularly close to guarantor Stay (for example, the dotted line seen in Figure 95 and Figure 96) during feature 3244.Go to Figure 98 to Figure 102, the framework bonding pad of framework 3310 The deformation of domain 3312 and obstruction part 3314 is according to the amount for allowing deformation and the region of deformation generation by using flank 3294 And controlled.In an example of this technology, with hindering being separated around part 3314 and against the obstruction portion Points 3,314 four flanks 3294, but more than four or less than four flanks are also possible.Flank 3294 would interfere with part The region of 3314 deformation is limited to the region adjacent only to keeping characteristics 3244,3245.Flank 3294 can also be against supercharging The inner surface of join domain 3240 and resist its deformation, with when pumping chamber 3200 is engaged with framework 3310 in these contact points Place provides the more firmly engagement between supercharging join domain 3240 and framework join domain 3312.Figure 102 to Figure 105 is gone to, Show the supercharging join domain 3240 independently of pumping chamber 3200, the supercharging join domain 3240 of pumping chamber 3200 can have recessed Mouth 3295 is with corresponding with flank 3294.Recess 3295 can be inclined-plane, with during the assembling of pumping chamber 3200 and framework 3310, Minimize friction of the supercharging join domain 3240 relative to flank 3294.Once crook 3246 is promoted to enough amounts, hook With the outside buckle of radial direction, position just is kept to cause crook 3246 to be presented on shown in Figure 90 for shape portion 3246.The card Pull and result in user's audible voice (for example making one the click trusted), with to having built up the user correctly connected Or patient provides feedback.In position is kept, the rear surface 3246.2 of crook 3246 and the guarantor of framework join domain 3312 Hold surface 3312.2 to engage, as shown in Figure 90.In an example of this technology, this makes one the click trusted with by shape Facilitated into the supercharging join domain 3240 (hardness is greatest around in supercharging join domain 3240) of enough hardness.This Individual hardness can be completed by overmolded manufacture.

In order to promote ease for use, overmolded technology is used in mask designs, component is can recognize that to reduce user/patient Quantity.The part for constituting the framework 3310 and conduit sub-component 4180 is overmolded fully integrated frame assembly 3001 In.These parts include framework 3310, two magnets 10340 and tubulature 4180 on underarm 10330.Rotate adapter It is attached to the distal end of tubulature 4180 later with rotary body 4190.Once assembling, this integral framework 3310 and from arm 10320, 10330 to rotation body end 4190 short-range missile tube assembly 4180 be designed to without dismounting in the case of can manipulate, clean and Sterilization.Framework 3310 is used as the underframe of spacer assembly 3002, and it is connected by snap features or join domain 3312,3313, and Additionally provide in sealing surfaces to realize that pad 3100 arrives the aeroseal of framework 3310.

Rotary components 4190 itself are made up of two parts for being forever assembled into a unit.Rotate 4190 pairs of adapter It is connected between tubulature 4180 and rotary body.Rotary components can be in rotation adapter 4190 and PAP system air delivery pipes Rotated between 4178 full 360 °.

As that can see in Figure 90, the surface of framework join domain 3312 and crook 3246 angulation in some way Degree, to facilitate being slidably connected between pumping chamber 3200 and framework 3310.For example, as described above, preceding surface 3246.1 and introducing Surface 3312.1 can be formed with the angle corresponded to each other so that these relatively easily can be slided each other towards the angle on surface Dynamic engagement.Similarly, rear surface 3246.2 and holding surface 3312.2 can be angled with respect to each other to contribute to framework 3310 and pumping chamber 3200 once connect.Angle between rear surface 3246.2 and holding surface 3312.2 is chosen to The pulling force for for example forming the axis of structure 3100 approximately along sealing and applying is enough to cause crook 3246 to curve inwardly, so that will Pumping chamber 3200 discharges from framework 3310.This pulling force does not require patient 1000 first for example by extruding in the longitudinal direction Pumping chamber 3200 makes the crook 3246 radially-inwardly deflect.Conversely, because involved angle, the radial direction of crook 3246 is inclined Turn only as the result of the axial tension of application to occur.In an example of this technology, supercharging join domain 3240 is inclined Turn and dismantle pumping chamber 3200 all by shrinking pumping chamber 3200 (for example, in the horizontal chi in pumping chamber 3200 from framework 3310 Very little upper (left and right) extrudes the pumping chamber 3200) and pull pumping chamber 3200 to perform away from framework 3310.

As that can see in Figure 90, pumping chamber 3200 via supercharging join domain 3240 be attached to framework 3310 and Keeping characteristics 3244 engage framework join domain 3312 by crook 3246.Also show in this view, framework bonding pad The holding surface 3312.2 in domain 3312 and the rear surface 3246.2 of crook 3246 are engaged with each other and flushed.For patient for general Pumping chamber 3200 is separated from framework 3310, and patient 1000 must pull pumping chamber 3200 with enough power relative to framework 3310, To overcome holding surface 3312.2 relative to the resistance on rear surface 3246.2.In an example of this technology, to pumping chamber 3200, which carry out contraction, reduces the axial tension needed for separating pumping chamber 3200 from framework 3310.This resistance can be " tuned ' Or it is selectively adjusted aspiration level by changing angle that these surfaces 3312.2,3246.2 are engaged with each other.Relatively In direction applied by patient 1000, power for separating pumping chamber 3200 from framework 3310 closer to these vertical surfaces 3312.2nd, 3246.2, bigger power is more needed to cause separation.This angle is shown as β in Figure 91, wherein rear surface 3246.2 are at an angle of relative to (pulling direction with the axial direction of pumping chamber 3200 to framework 3310 corresponding) nominal vertical pivot 3246.4.When When β increases, the power rising needed for separating pumping chamber 3200 from framework 3310.In addition, when β increases, separating for patient 1000 It will feel more unexpected.In one example, for patients, it has been found that about 75 degree of angle beta produces the comfort of separation. In further example, β can from 30 degree to 110 degree or from 40 degree to 90 degree or the change from 65 degree to 85 degree, with produce for The preferable resistance levels of separation.This has been chosen to make the possibility of accidental separation to minimize, and only allows patient 1000 Separation intentionally.

Angle angle α between the nominal longitudinal axis 3246.4 and preceding surface 3246.1, " can equally be tuned " or optionally Regulation, to meet the specified level of power when pumping chamber 3200 is attached to framework 3310 by patient 1000., will when angle α increases Power needed for keeping characteristics 3244 are engaged with framework join domain 3312 increases, and engages the trouble of these components 3244,3312 The attachment of person is felt to become more unexpected.In other words, when the preceding surface 3246.1 of keeping characteristics 3244 is along framework join domain When 3312 introducing surface 3312.1 is slided, patient 1000 reduces such as angle α and undergoes smoother engagement and feel.One In individual example, it has been found that about 30 degree of angle α produces the comfort of attachment to patient 1000.In further example, angle [alpha] can To change from 50 degree to 70 degree or from 15 degree to 60 degree, to produce the preferable resistance levels for attachment.

Further, since the engagement of pumping chamber 3200 and framework join domain 3312 and the sensation and power that separate can be with tuned Or optionally adjust independently of one another, so angle α and β can be selected as making patient feel resistance levels for engagement with Resistance levels for separation are different.In an example of the technology, angle α and angle beta may be selected so that angle beta is more than angle α, to cause patient's sensation smaller for the resistance of separation for the resistance ratios of the attachment of pumping chamber 3200 and framework 3310.Change speech It, for framework 3310 is connected with pumping chamber 3200, patient 1000 may feel to be more difficult to disconnect them.

As that can see in Figure 82, an example of this technology includes a pair of keeping characteristics 3244,3245.Also regarded at this Shown in figure, exemplary keeping characteristics 3244,3245 sizes are different.In particular, this view show be arranged on supercharging to connect The keeping characteristics 3245 connect on the lower part in region 3240 are more special than the reservation being arranged on the upper part of supercharging join domain 3240 Levy 3244 narrower.By the way that by the different sizes of the formation of keeping characteristics 3244,3245, patient 1000 can only be orientated at one will Pumping chamber 3200 is attached to framework 3310 and prevents dislocation.This arrangement is illustrated in Figure 82.This is avoided during being attached Patient baffles, and minimizes the damage to patient interface 3000 that may be produced from incorrect attachment, it is ensured that sealing shape Correct orientation is in into structure 3100, to provide the appropriate sealing of the air flue relative to patient and by the way that contact force is reduced or avoided Concentration and provide comfortable, especially at the upper lip of patient 1000.

In Figure 88, framework join domain 3312 is shown as engaging with corresponding keeping characteristics 3244.It is broader to retain Feature 3312 is engaged with the suitable framework join domain 3244 of corresponding size.In example as shown here, narrow reservation is special Levy 3245 be designed and sized to correspond to narrow forward frame join domain 3313, although their engagement is sightless.It is all Such as situation about being engaged with the corresponding framework join domain being uniquely sized uniquely is designed as in the size of a keeping characteristics Under, such a arrangement has the advantage that patient will only be able to that pumping chamber 3240 is attached into framework 3310 in an orientation. By the orientation for limiting attachment, it is therefore prevented that patient 1000 undeservedly assembles patient interface 3000 and the patient due to improper assembling connects Mouthfuls 3000 and receive the treatment of suboptimum.The arrangement described relative to this particular example of the technology is favourable to patient 1000 , to tackle：Patient is assembled because visual problems or patient 1000 (such as may sleep preceding in bedroom) in dark room Interface 3000 and may be difficult to see how correctly conjugative component, if because the component of patient 1000 is not by just Patient interface 3000 cannot be assembled completely by really aliging.

The angle on preceding surface 3246.1 and rear surface 3246.2 in crook 3246 is critically important, to provide resistance Optimised quantity assembles and dismantled patient interface 3000.Keeping characteristics 3244,3245 and corresponding framework connection are also described above The benefit that region 3312,3313 is sized so that ensure the correct orientation of component in assembling.Make keeping characteristics 3244, 3245 and framework join domain 3312,3313 be formed in a suitably dimensioned and can be directed to help by pumping chamber 3200 on framework 3310. In other words, framework join domain 3312,3313 and keeping characteristics 3244,3245 can be dimensioned as each other close one Cause, to cause the periphery of framework join domain 3312,3313 and the periphery of keeping characteristics 3244,3245 to help keeping characteristics 3244th, 3245 instruct and snap in corresponding framework join domain 3312,3313.This can be beneficial to because disease (is such as closed Section is scorching) and the patient with limited mobility weakens the feelings of vision in the dark room before sleep or due to limited eyesight Patient interface 3000 is assembled under condition.In addition, by keeping characteristics 3244,3245 and the formation of framework join domain 3312,3313 Size is close consistent each other, and the sealing that this is used to ensure between pumping chamber 3200 and framework 3310 is by promoting the two Secure connection between component is kept.In addition, between keeping characteristics 3244,3245 and framework join domain 3312,3313 Close consistent can be used for promoting equal alignment of the pumping chamber 3200 on framework 3310.In an example of this technology, 0.3mm to 2mm difference can be incorporated between keeping characteristics 3244,3245 and framework join domain 3312,3313.

It is to be further understood that the connection between the framework 3310 being described above and below and pumping chamber 3200 can be with it He is used together the mask of type.Such feature is readily applicable to foil facial mask.Sealed mask is (for example under the bridge of the nose Compact nose cup or compact foil facial mask) connection features described herein can also be combined.In addition, lacking forehead branch The mask of support can also include these connection features.It is also envisioned that, it is included in the sheet of sealed mask below nose The example (such as nose stretcher/nose flange 3101) of technology can also use these connection features.

6.3.4.1.2 pumping chamber and framework are attached and disassembly sequence

Figure 93 to Figure 97 shows the coupling part 3202 of pumping chamber 3200 and the framework join domain 3312 of framework 3310 The order of cross-sectional view.The sequence view shows pumping chamber 3200 to the process of the attachment of framework 3310.Although these views are only The attachment of 3244 to one framework join domain 3312 of a keeping characteristics is shown, it will be appreciated that, there may be multiple Keeping characteristics 3244 and multiple framework join domains 3312, such as Figure 53 can see to Figure 55, Figure 69 and Figure 81 and on As face is discussed.Therefore, in the attachment sequential process of pumping chamber 3200 and framework 3310, there may be described, complete Into multiple examples of the attachment order of the complete attachment of pumping chamber 3200 and framework 3310.

Figure 93 shows the cross section of the coupling part 3202 of pumping chamber 3200 and the framework join domain 3312 of framework 3310 Figure, wherein coupling part 3202 and framework join domain 3312 are closer to each other but do not contact.Arrow represents the He of coupling part 3202 Framework join domain 3312 is directed to together.It should be appreciated that for these views, for simplicity, not comprising increasing The extention of pressure chamber 3200 and framework 3310.Therefore, it is also contemplated that, framework join domain 3312 and framework bonding pad The obstruction part 3314 in domain 3312 is two parts of framework 3310, such as can be seen that in Figure 90.In addition, with Afterwards it should be appreciated that the obstruction part 3314 of frame connection part 3312 and frame connection part 3312 will pass through attachment order And be moved relative to each other.Return to Figure 93, this view illustrate when sealing lip 3250 and keeping characteristics 3244 all with framework 3310 when not contacting, and the sealing lip 3250 is indeformable and the keeping characteristics 3244 are indeformable.

Figure 94 shows the crook of holding member 3244 for starting to contact with the framework join domain 3312 of framework 3310 3246.Specifically, this view show that the crook 3246 that is contacted with the introducing surface 3312.1 of framework join domain 3312 Preceding surface 3246.1.In this view, keeping characteristics 3244 and framework join domain 3312 are only just contacted each other so that retained Feature 3244 is not deflected.In addition, sealing lip 3250 is not deflected, because its obstruction not yet with framework join domain 3312 Part 3314 is contacted.As described above, the angle [alpha] on preceding surface 3246.1 will start influence patient 1000 to pumping chamber 3200 and framework The engagement of join domain 3312 and the resistance felt, because surface will be taken to and be introduced in preceding surface 3246.1 3312.1 CONTACT WITH FRICTION.

Figure 95 shows the pumping chamber 3200 and framework 3310 further along attachment order so that keeping characteristics 3244 lead to Cross and contact and deflect with framework join domain 3312.As can be should regarded it can be seen from the figure that, framework join domain 3312 With the obstruction part 3314 of framework join domain 3312 closer to connecting portion 3202.And shown in this view, crook 3246 Preceding surface 3246.1 be in contact with introducing the part of closer holding surface 3312.2 on surface 3312.1.In other words, It can be seen that crook 3246 has been shifted to the attachment with framework join domain 3312 and moved relative to the position shown in Figure 94 It is dynamic.As previously described, the supercharging join domain 3240 of coupling part 3202 and pumping chamber 3200 can also be produced from by patient 1000 Raw convergent force deflection.Figure 95 is also shown that keeping characteristics 3244 have been deflected simultaneously by being contacted with framework join domain 3312 And the profile of the keeping characteristics 3244 shown in phantom under undeformed state.Figure 95 also show that sealing lip 3250 not yet with frame The obstruction part 3314 of frame join domain 3312 is contacted, also, therefore, the seal lip 3250 is indeformable.Although, in this view Not shown in, but be to be further understood that due to the power that framework join domain 3312 and keeping characteristics 3244 are pressed together, institute It can be deflected with framework join domain 3312 away from keeping characteristics 3244.

In addition, in Figure 96, pumping chamber 3200 and framework 3310 be almost attached and keeping characteristics 3244 almost completely with Framework join domain 3312 is engaged.In this view, keeping characteristics 3244 are still deformed but crook 3246 and framework bonding pad The different piece contact in domain 3312.Specifically, the rear surface 3246.2 of crook 3246 now with framework join domain 3312 Holding surface 3312.2 is contacted.Further, since the thing of the angle under surface 3246.2 and holding surface 3312.2 are in contact with each other afterwards Real, keeping characteristics 3244 and framework join domain 3312 can pass through its undeformed state of the return of the keeping characteristics 3244 of deflection Tropism and be advanced in engagement, reached and be effectively drawn together these parts after certain insert the distance.Figure 96 The profile of the keeping characteristics 3244 in undeformed state is also show with dotted line.In addition, in this view, it can be seen that sealing Lip 3250 is contacted with the obstruction part 3314 of framework join domain 3312.At this point, in attachment order, sealing can be opened Beginning is formed by the contact with the obstruction part 3314 of framework join domain 3312 of sealing lip 3250.Sealing lip 3250 can also lead to The contact against the obstruction part 3314 of framework join domain 3312 is crossed to deflect slightly.

Figure 97 shows that pumping chamber 3200 and framework 3310 are connected by the crook 3246 of keeping characteristics 3244 with framework The engagement in region 3312 and be attached completely.In this view, holding surface 3312.2 can be with the rear flush relative of surface 3246.2. Keeping characteristics 3244 can also be deflected no longer by the contact with framework join domain 3312.Keeping characteristics 3244 are deflected from it Or deformation state returns to undeformed state, as shown in Figure 96, when crook 3246 and keeping characteristics 3244 are shown in Figure 98 Position can produce audible click when being moved to the position shown in Figure 97.This makes one the audible click trusted Clatter sound can be favourable, be that it provides the feedback that pumping chamber 3200 and framework 3310 are fully engaged to patient 1000.It is logical Cross and give the offer of patient 1000 this feedback after the completion of engagement, patient 1000 can cherish following confidence to use patient interface 3000：When patient 1000 is sleeping and receives treatment pumping chamber 3200 and framework 3310 be attached securely and without departing from.

In addition, when required level in sealing contact can be like that attached as shown in Figure 97 in pumping chamber 3200 and framework 3310 Realize.It can be seen that sealing lip 3250 is deflected against the obstruction part 3314 of framework join domain 3312.By as shown in figure Deflection, sealing lip 3250 can promote its own with enough due to the tendency for returning to its undeformed state of sealing lip 3250 Power abuts the obstruction part 3314 of framework join domain 3312 so that desired sealing is generated between these components. In addition, when application for the treatment of due to the air pressure increase in pumping chamber 3200, the sealing lip 3250 is forced towards framework bonding pad The part 3314 in domain 3312 is deflected, so as to add the sealing force in this region.When the framework 3310 of pumping chamber 3200 is engaged, Even in forming compression seal between holding structure 3242 and framework join domain 3312, cause with air pressure inside increase Also pressure activation sealing is formed when engagement is strengthened between sealing lip 3250 and the part 3314 of framework join domain.In some examples In, compression seal may not be airtight, result in undesirable leakage.

In addition, the compression of larger numbers of part is to form compression seal if desired, this may hinder pumping chamber 3200 Easy attachment with framework 3310 and separate, it may be necessary to which more than single hand performs operation or needs the effort of significant quantity.Cause This, in an example of this technology, compression seal is mainly used in keeping rather than sealed purpose, and pressure activation sealing is main For creating and safeguarding gas-tight seal purpose.It is to be understood that, such sealing effectiveness can occur in pumping chamber 3200 and frame The perimeter of joint between 3310.For example, Figure 92 show at the region separated with keeping characteristics 3244 relative to Sealing lip 3250 under the similar deviation state of framework join domain 3312.In addition, in Figure 80 and 81 as can be seen that for example, Sealing lip 3250 extends around the periphery of pumping chamber 3200.Pass through the week of the engagement between pumping chamber 3200 and framework 3310 The seal lip that extended internally around side 3250, the sealed horizontal needed for sealing can be realized in this whole region, so that anti- Only undesirable pressurized gas leak.

However, it should be understood that sealing lip 3250 can be pressed in framework company to promote the power of these isolation of components Connect on 3312 obstruction part 3314.But, due to rear surface 3246.2 and the framework join domain 3312 of crook 3246 What the structure engagement of holding surface 3312.2 and the frictional force that causes should be enough to resist sealing lip 3250 returns to undeformed state And the power of trend that separates pumping chamber 3200 with framework 3310.

For the dismounting of pumping chamber 3200 and framework 3310, it should be understood that this process is substantially said process Reverse order.In other words, patient 1000 can be by pulling these parts by pumping chamber 3200 and frame in opposite direction 3310 separate, and Figure 97 view can be separation process beginning, and Figure 25 can represent pumping chamber 3200 and framework 3310 views being completely separated.Contraction or contraction supercharging join domain of the pumping chamber 3200 close to supercharging join domain 3240 3240 and away from framework 3310 pull can assist from framework 3310 remove pumping chamber 3200.It is also envisaged that patient 1000 can be with Pumping chamber 3200 is shunk in any place, for its purpose is clamped, and simply to pull away from frame 3310.What is pulled is same When twist motion can also assist in and depart from pumping chamber 3200 from frame 3310.

6.3.4.1.3 hardware is connected to hardware

Supercharging join domain 3240 and framework 3310 can be assembled and be attached, as shown in Figure 93 to Figure 97.As described above, Semi-rigid material can be included by being pressurized join domain 3240 and/or holding structure 3242, and the silicon of such as high rigidity (compares pumping chamber 3200 higher hardness)/TPE, plastics, nylon, polypropylene, polyamide and/or makrolon.Being pressurized join domain 3240 can be with Constructed in the form of continuous ring or ellipse, two C-clamps, a C-clamp or single serialgrams, but only surround increasing A part for pressure chamber 3200.Clip may be used as spring clip and be formed with C-shaped section or double C shape section.The spring of spring clip Power can pass through the supercharging join domain for hindering the stretching, extension of part 3314 against framework join domain 3312,3313 or framework 3310 3240 elasticity is provided.In another example, clip-type can be unnecessary, and not used for bonding pad Domain 3312,3313 engage supercharging join domain 3240 and/or holding structure 3242 in the case of, only supported feature 3244, 3245 are permanently and directly connected to pumping chamber 3200.It is also envisioned that, an example of this technology can also include Following framework 3310, the framework 3310 is comprising same or similar semi-rigid material to be used as supercharging join domain 3240.It is logical Supercharging join domain 3240 and the pumping chamber 3310 of manufacture semi-rigid material are crossed, " hardware is to hardware " connection or bonding docking can quilts Create, for example, releasable hardware is connected to hardware.Structure with supercharging join domain 3240 and framework join domain 3312 is special This " hardware is to hardware " connection of combination is levied, pumping chamber is provided to patient 1000 when can work as assembling patient interface 3000 The self-confident of connection between 3200 and framework 3310 is felt (for example, audible being clasped or making one what is trusted by providing Audible click).Because the secure fit between pumping chamber 3200 and framework 3310 helps to ensure that patient 1000 passes through Patient interface 3000 receives optimal treatment, so the confidence that is ease for use and having realized secure fit provided to patient 1000 Design be beneficial.Hardly possible as described herein can also be beneficial to Hard link, be that it can be to forming knot by sealing Sealing increase stability made by structure 3100.This with firmly to be flexible coupling or it is soft be contrasted to being flexible coupling, it is and hard to soft at this Connection or it is soft to being flexible coupling in, one or all in pumping chamber and framework is made up of soft material, and this causes with arthritic Both hands are difficult to correct engagement plenum and framework easily, particularly in the case of dark room." hardware is to hardware " is connected Sealing is additionally provided to form the simple attachment of structure 3100 and framework 3310 and be attached again.

Although keeping characteristics 3244,3245 are to be described as being arranged in pumping chamber 3200 and join domain 3312,3313 Be arranged on framework 3310, but the keeping characteristics that the position can be switched on framework, and and pumping chamber on bonding pad Domain.Furthermore, it is possible to the keeping characteristics and join domain of a part be combined, with the keeping characteristics corresponding to other parts and bonding pad Domain.

6.3.5 the method for making pumping chamber

The process of manufacture pumping chamber 3200 may include following steps：The molding supercharging join domain 3240 in the first instrument, The supercharging join domain 3240 of molding is removed from the first instrument, supercharging join domain 3240 is inserted into the second instrument, and Molding includes a part for the pumping chamber 3200 of coupling part 3202 in the second instrument.Being pressurized join domain 3240 can be with connecting Socket part point 3202 is chemically bonded and/or mechanical interlocked.

In one form, sealing lip 3250 is constructed and arranged to when pumping chamber 3200 is fitted together with framework 3310 When interference framework join domain 3312 obstruction part 3314 (Figure 90).In use, cause sealing lip 3250 when and framework Away from resting position (Figure 89) elastic bending during the assembling of obstruction part 3314 of join domain 3213, and it is used as elastomeric material As a result at least part is against hindering part 3314 (Figure 90) to promote, to resist or prevent in sealing lip 3250 with hindering part Air leakage between 3314.Although sealing lip 3250 has been described as setting together with pumping chamber 3200, seal lip 3250 Also it may be disposed on framework 3310.Although describing a sealing lip, two or more sealing lips can be set, wherein At least one sealing lip is set together with pumping chamber 3200 and at least one sealing lip is set together with framework 3310.

6.3.6 position and rock-steady structure 3300

It is noted that in a kind of form of this technology, the portion of multiple architectural feature formation positioning and rock-steady structure 3300 Point, such as headgear assemblies (it may be referred to simply as headband).In the alternative form of this technology, these features it is one or more Feature is located on framework 3310.

The sealing of the patient interface 3000 of this technology forms structure 3100 in use can be by positioning and rock-steady structure 3300 are maintained at sealing station (Figure 75, Figure 76 and Figure 166).In one form, positioning and rock-steady structure 3300 include headband. It should be appreciated that in a kind of form of this technology, positioning and rock-steady structure 3300 are referred to alternatively as headband.

Headband band 3301 can be detachably connected to a part for patient interface 3000, such as via framework 3310 Upper arm 10320 and underarm 10330 are connected to positioning and rock-steady structure 3300.

Positioning and rock-steady structure 3300 may include two pairs of side strips：It is connected to neck band 10227 or circular crown band 10225 a pair of top side strips 10230 and a pair of bottom side strips 10220.Top side strip 10230 is connected to upper head Band tie point 10325, to limit between eyes and ear can be positioned along the side of patient facial region, from patient 1000 Extend substantially into the main headband ring of hat band 10225.Side strip 10230,10220 includes adjustable shackle (Velcro^TM) even Connection mechanism 950 is to be connected to the headband tie point 10325,10331 on the headband connector 800 or framework 3310 of Y shape.

Tie point 10325,10331 includes：Retention mechanism, the connection for holding head counterband tape 3301 and connector；With And separation adjusting mechanism, for adjusting the tension force of headband band for sealing.The separation of retention mechanism and governor motion allows Headband band 3301 can be independently adjusted the connection of headband band 3301 and connector.It is separately adjustable to allow " to put things right once and for all special Levy ", this allows headband band 3301 to adjust or " setting ", and then stays in this when dressing or removing headband band 3301 The position of individual regulation, so as to allow patient 1000 " to forget " setting before them.

Positioning and rock-steady structure 3300 may include two pairs of side strips：It is connected to neck band 10227 or circular crown band 10225 a pair of top side strips 10230 and a pair of bottom side strips 10220.Top side strip 10230 is connected to upper head Band tie point 10325, to limit between eyes and ear can be positioned along the side of patient facial region, from patient substantially Extend to the main headband ring of hat band 10225.Upper head counterband tape 10230 includes adjustable Velcro^TMShape bindiny mechanism 950 With the upper head band tie point 10325 being connected on the upper arm 10320 of framework 3310.

Exemplary positioning and rock-steady structure 3300 is the PCT Publication WO 2010/ submitted on May 28th, 2010 Disclosed in 0135785, entire contents are incorporated herein by reference.

In one example, the sealing of the patient interface 3000 of this technology formed structure 3100 when in use by positioning and Rock-steady structure 3300 is maintained at sealing station.

In addition, in another form of this technology, the sealing of the patient interface 3000 of this technology forms structure 3100 and passed through Sealing station is maintained at by the four point attachment to positioning and rock-steady structure 3300.

Positioning and rock-steady structure 3300 remain to spacer assembly 3002 on the face of patient 1000.The quilt of headband band 3301 It is formed to conform to the head of patient 1000.Headband band 3301 can be by reducing the high-quality rolling fabric (premium of facial striped Rolled edge fabric) it is made, and be comfortable, it is easy to wear.Headband band 3301 includes the circle for enumerating pileum Hat construction.The top counterband tape 10230 of two pairs of horizontal orientations from apical cap band 10225 extend to patient facial region front and by Fixed to framework 3310.The end of two top counterband tapes 10230 is threaded through upper arm 10320, turns back, then with regulation or Fastening member (such as Velcro^TM950) hook-shaped of shape fastens.These top counterband tapes 10230 are beneficial to the nasal bridge region week of patient The aeroseal enclosed.Following counterband tape 10220 is similarly threaded through and using the Velcro of same type^TMShape is consolidated for hook-shaped 950 Fixed to two overmolded magnetic head band folders 10210.Headband folder 10210 is positioned oneself and engages the underarm positioned at framework 3310 Two corresponding half (halve) on 10330.The two following counterband tapes 10220 keep silicon to seal, and to form structure 3100 tight By the face of patient, and bottom and side that they make sealing form structure 3100 can realize the facial air to patient Sealing.

The length of headband band 3301 is by untiing Velcro^TMShape hook-shaped 950 and pass through upper arm 10320 or headband Press from both sides 10210 sliding strips 10220,10230 and by fastening hook-shaped 950 again, and easily adjust.Once the quilt of hook tabs 950 Fastening and setting, headband just can press from both sides one in 10210 by separating head band and rapidly and easily remove.Velcro^TMShape Help the setting of holding head band for hook-shaped 950 in case using next time.As shown, headband by cutting into strips 10220,10230, 10225th, 10,226 three layer laminates (fabric, foam and fiber) and neck band 10227 are ultrasonically welded together and made Into.In one example, at least some bands (such as band 10220,10230,10225,10226) can pass through vertical cut shape Into and being in line form using ruler-shaped, for example to save cost, if because they are cut from flaky material, wasted Material it is less.

Figure 115 to Figure 121 shows a form of order that patient interface 3000 is coupled to patient according to this technology Step.For example, sealing forms structure 3100 and engages patient facial region, and apical cap band 10225, neck band 10227, side first Band 10226 and following counterband tape 10220 are preced with by the top on the head of patient, as shown in Figure 115.Apical cap band 10225 And side hat band 10226 engages the head of patient to encapsulate pileum (Figure 116), the head then associated with following counterband tape 10220 Underarm 10330 with folder 10210 and framework 3310 is engaged (Figure 116).Top counterband tape 10230 and/or following counterband tape 10220 length is manually adjustable (Figure 118 and Figure 119).Finally, air loop 4170, which may be coupled to, is supplied to patient interface Tubulature 4180 (Figure 120), then patient interface can adjust or finely tune manually on face with for comfortable and laminating (figure 121)。

Such as Figure 122 and Figure 123, patient interface 3000 can by separate a headband press from both sides 10210 (Figure 122) and The above-head of patient pulls up headband (Figure 123) and rapidly and easily removed from the head of patient.

Figure 124 to Figure 126 shows each step of a form of dismounting patient interface 3000 according to this technology.Example Such as, Figure 124 shows the Velcro for the top counterband tape 10230 untied and pulled from upper arm 10320^TMShape hook-shaped 950, figure 125 show to extrude in its side or shrink the spacer assembly 3002 so that it to be removed from framework 3310, and Figure 126 shows to be slided The upper arm set 10312 for going out and being removed from upper arm 10320.

Figure 127 to Figure 130 shows a form of each step for re-assemblying patient interface 3000 according to this technology. For example, Figure 127 shows the spacer assembly 3002 for extruding and being pushed into its side and engaged with framework 3310, Figure 128 show by 10312, the Figure 129 of upper arm set for sliding into and being assembled into upper arm 10320 shows to be threaded through the top counterband tape of upper arm 10320 10230 Velcro^TMShape hook-shaped 950, and Figure 130 shows to be threaded through headband folder 10210, turns back and then fastened The Velcro of following counterband tape 10220^TMShape hook-shaped 950.

Figure 64 to Figure 67, Figure 72, Figure 84 and Figure 86 show to be used for positioning and rock-steady structure according to disclosed technology 3300 headband band 3301.The hat component of headband includes neck band 10227, side hat band 10226 and apical cap band 10225.Neck band 10227 is connected to side hat band 10226 and following counterband tape 10220.It is preced with band 10226 and apical cap in side Band 10225 is connected in thinning coupling part 10223 to provide bigger flexibility.Thinning coupling part 10223 can With with substantial V-shape, and preferably at least partly separate each other.Thinning coupling part 10223 can be weld part Point.

Neck band 10227 includes two main lateral edges 10228,10229.In this illustration, main lateral edges 10228th, 10229 shape with general curved.Main side 10228,10229 and two secondary lateral edges 10231,10232 Interconnection.Secondary lateral edges 10231,10232 are located at distal end or the sidepiece of the symmetry axis of neck band 10227.Secondary lateral edges 10231st, 10232 respectively include three marginal portions.

The width of neck band 10227 reduces in the concave curved surface part of relative main lateral edges 10228,10229, Measured on the vertical direction of the axis vertical with the symmetry axis of neck band 10227.Band 10226 is preced with respective upper company in side Socket part point 10222 is connected or connectable to neck band 10227.Following counterband tape 10220 is with respective lower coupling part 10221 are connected or connectable to neck band 10227.The lower coupling part 10221 of described example is approximately perpendicular to respective The main shaft of lower slice header band 10220 and extend.Here, upper coupling part 10222 is oriented is preced with band with corresponding side 10226 extension principal axis line is at an acute angle.

The each band 10230,10220 for being connected to framework 3310 is provided with hook piece 950.By by apical cap band 10225 are soldered to the side hat band 10226 for being soldered to following counterband tape 10220, obtain final three-dimensional hat component.

6.3.6.1 magnetic head band is engaged

Position and a kind of juncture between rock-steady structure 3300 and framework 3310 can be by magnetic engagement.This is Patient 1000 provides convenience, because the magnetic engagement can play the memory effect of " putting things right once and for all ", it is to avoid whenever patient 1000 have to when taking and take patient interface 3000 adjusts the length of headband band 3301 and uses hook piece 950.Magnetic Property engagement also provide it is convenient using and under low no-load state be to provide help with the scorching patient 1000 of hand joint because When they are closer to each other, headband folder 10210 intuitively can be guided or be oriented into the lower headband tie point on underarm 10330 by magnetic attraction 10331.This provide it is self-aligned, and successfully engage when audible click can allow the quick assembling of patient 1000 They quickly start or continual cure.

Underarm 10330, which can be included at lower headband tie point 10331, is encapsulated in or is embedded in the remote of underarm 10330 Magnet 10340 in end.Magnet 10340 be packaged in completely with the identical material of underarm 10330.In instances, it can pass through Such as overmolded or ultrasonic bonding provides the magnet being enclosed in underarm.For example by polar attraction by magnet 10340 It is magnetically attracted to the magnet 10216 in embedded headband folder 10210.Headband folder 10210 is positioned at positioning and rock-steady structure 3300 Bottom head strap band 10220 on and can be moved freely along the bottom head strap band 10220 of the positioning and rock-steady structure 3300. Figure 109 shows the cross section of headband folder 10210 and the magnet 10216 being embedded within.As indicated, headband folder 10210 is provided Limiting allows headband band 10220 to be threaded through slit therein or the cross bar (cross-bar) 10218 in space 10217.In reality In example, slit 10217 is elongated, and it has the longitudinal axis with nominal vertical diameter parallel when being positioned to use.Work as headband When folder 10210 engages with headband tie point 10331 and applies headband tension force, slit is made by underarm 10330 and framework 3310 10217 is unimpeded.

Headband folder 10210 is oriented to and snapped to underarm 10330 by the magnetic attraction between magnet 10340 and magnet 10216 Lower headband tie point 10331.In addition to headband folder is mechanically engaged with lower headband tie point 10331, they are additionally aided under Certain engaging force of headband folder 10210 is provided at headband tie point 10331 to framework 3310.In instances, headband presss from both sides 10210 Hes Framework 3310 can form the sub-component of referred to as headband system.

Magnet 10216 is completely covered by the material for forming headband folder 10210.In the case of without any molding line, The outer surface of substantial smooth can be had by covering the material of magnet 10216.Similarly, magnet 10340 is also packaged in down completely In arm 10330.In the case of without any molding line, substantial smooth can be had by covering the material of magnet 10340 Outer surface.In addition in vision and aesthetically satisfactory, the material of covering magnet 10216 and magnet 10340 it is substantial Smooth outer surface makes any Relative friction and physics hinder to minimize, thus allows readily to rotate against.

With reference to Figure 70, headband folder 10210 can include being adapted to the lower headband tie point with the underarm 10330 of framework 3310 The mechanical structure of 10331 mechanical engagement or mechanical holding member 10215.Underarm 10330 is releasable using underarm 10330 Ground keeps the magnet 10340 of bottom head strap band 10220.In an example, mechanical holding member 10215 is the guarantor of semicircle shape Hold wall or convex wall, edge or edge, (such as referring to the semicircle or U-shaped cross-section of convex wall in Figure 70 and Figure 109), with The semicircle neighboring area machinery of the cylindrical part 10334 (for example, see Figure 57 and Figure 59) of lower headband tie point 10331 connects Close.That is, by the cylindrical part 10334 extended forward, the packaging of magnet 10340 provides convex surface 10335, and The convex surface 10335 can be mechanically coupled to the raised brim of the circumference of headband folder 10210.This is a kind of matching relationship, wherein, it is public Accessory (male part) is the semicircle neighboring area of cylinder or column part 10334 at lower headband tie point 10331, its Coordinate with female accessory, the female accessory is the circular space being limited in the raised brim 10215 of headband folder 10210 (referring to figure 70), that is to say, that convex wall or raised brim 10215 define the space for being adapted to receive headband tie point 10331.This geometry Mechanism is provided between public accessory and female accessory and is slidably matched or mechanical caging.For example, when applying headband tension force, machinery knot Structure prevents the linear transition on the direction substantial parallel with Frankfort horizontal direction of headband folder 10210.In instances, convex surface 10335 can will be at an angle of via cylindrical part 10334 or tilt to provide undercutting, so as to which headband folder 10210 is retained On cylindrical part 10334.Using the shearing force corresponding to the magnetic force between magnet 10216 and 10340, this circle plants matching Geometry also allows headband folder 10210 to be rotated by 360 ° relative to headband tie point 10331.That is, being connected by lower headband The magnet 10340 and convex surface 10335 that the cylindrical part 10334 of point 10331 is provided have substantial circular or oval horizontal stroke Section, when magnetic engagement, the circle or oval cross section can make headband press from both sides 10210 and its phase of raised brim 10215 Underarm 10330 is rotated, for example, twists and minimizes so as to the torsion for making following counterband tape 10220 when applying headband tension force.For example, working as By adjust headband band 10220 length apply headband tension force when, headband folder 10210 keep with underarm 10330 machinery and Magnetic engagement simultaneously rotates relative to underarm 10330.Magnet 10340 can completely be packed so that by plastic material thin layer by magnetic Body 10340 is completely covered on all surface.This material is identical with the plastic material for forming underarm 10330 and is therefore seamless , it is visually attractive in appearance and integrally formed.Magnetically sucking head band presss from both sides 10210 to the magnet 10340 of underarm 10330, to make With the middle ad-hoc locations that headband is pressed from both sides 10210 guiding and navigated on underarm 10330.Using previously described matching relationship, under Arm 10330 is mechanically engaged headband folder 10210, to keep reliable mechanical engagement until patient 1000 unclamps intentionally.Figure 112 is also Show the magnetic engagement and mechanical engagement between underarm 10330 and headband folder 10210, the raised brim 10215 of headband folder 10210 Engaged with the convex surface 10335 of the cylindrical part 10334 of underarm 10330.

According to the example of this technology, the example benefit of magnetic head band engagement is that headband folder 10210 includes low profile, than Volume is such as caused to diminish, physics obstruction diminishes, low gravitation and more visions attract.Other example benefit is to improve Usability, such as by headband press from both sides 10210 directions of breakaway forces departed from from underarm 10330 be in particular directions it is low, still It is high in the other direction.This set prevents the accidental disengaging in use but allows readily intentionally to depart from.Another Example benefit is, because the headband of underarm 10330 presss from both sides the shape and the geometry structure of matching of 10210 and cylindrical part 10334 Make, headband folder magnet 10216 be accurately directed to underarm magnet 10340, that is to say, that when at a distance of specified distance by magnetic When body 10216 and magnet 10340 are pulled together, magnet 10216 and the flat surface of magnet 10340 will substantially relative to each other Center alignment (such as referring to Figure 112).

In another example, the raised brim of the circumference of holding member 10215 can have recess, and this allows clip to be used for Other are in the mask being undesirable to have in the case of rotating, such as oral nose mask.Headband tie point has in this oral nose mask Therefore the protuberance of engagement recesses simultaneously prevents from rotating against.

At the inner surface of mask 3000, when 10340 magnetic engagement of magnet of headband folder 10210 and underarm 10330, Magnetic field intensity at the headband folder 10210 assembled and the surface of framework 3310 is less than as gaussmeter or magnetometer measures 380mT.Magnetic field intensity can be about 160mT to about 190mT.Magnetic field intensity can be about 180mT.According to international non-electrical From radio protective committee (ICNIRP) issue in health physics 96 (4)：504-514；2009, it is entitled：On exposure In the guideline of the limitation of magnetostatic field, magnetic field intensity should not exceed 400mT.In addition, if magnetic field intensity is too strong, for Patient 1000 is difficult easily to separate headband folder 10210 from underarm 10330.If magnetic field intensity is too weak, headband folder 10210 can become magnet 10340 that is frequent and can significantly decreasing cooperation and magnetic from the accidental separation of underarm 10330 The guiding and alignment function of body 10216 and pair and patient 1000 without benefit.In instances, magnet 10340 and magnet 10216 Can be ferrimagnet, permanent magnet or electromagnet.

Headband folder 10210 is self-positioning by the magnetic attraction with underarm 10330, and this is not helped visually, such as, In one dark room, especially to gerontal patient or arthritic.In addition, headband folder 10210 provide it is audible and It is tactile feedback with show and underarm 10330 successfully mechanically engage.The guide-localization of magnet 10216 and magnet 10340 is not It is individually used for keeping the engagement between underarm 10330 and headband folder 10210.When by tensing the application headband of headband band 3301 During power, the mechanical engagement between headband folder 10210 and underarm 10330 prevents headband from pressing from both sides 10210 and departing from from underarm 10330.Although Two magnets have been described, it is also possible in the presence of a magnet (headband folder 10210 or underarm 10330) and a ferrite Material (headband folder 10210 or underarm 10330).

Manufactured by Sleepnet companiesFoil facial mask includes magnetic head band connector and adjustable forehead branch Support member.Mask has the pad full of gel and is permanently attached to the mask shell of relative stiffness.The revolution of ventilation Bend pipe extends from shell.A pair of magnets is placed in the shell of the side of adjacent housings.The middle section of each magnet is in Qi Ding Environment is exposed in portion and lower surface and is not covered by any plastic material.Similarly, each triangular shaped Magnet in headband folder is also exposed to environment at the top and bottom of it on surface.On the contrary, the magnet of this technology is all packaged in Or be encapsulated in plastic material, that is to say, that referring to Figure 109 and 112, show magnet 10216 and 10349 by top layer plasticity Material and bottom plastic material are maintained at headband and pressed from both sides in 10210/ underarm 10330, such as, in convex wall 10215 from bottom plasticity material In the case that material is prominent (that is, convex wall 10215 from the circumferential section protrusion around magnet 10216), this can minimize or Prevent the destruction caused by scraping to magnet and prevent from contacting with surrounding air to avoid aoxidizing or corrode.With Magnet in the shell of mask is compared, and the magnet 10340 in the underarm 10330 of framework 3310 in this technique is further Separate.It can only be incited somebody to action by the Breadth Maximum of shellMagnet in the shell of mask is separated, the maximum of the housing Width is less than the Breadth Maximum of pad.On the contrary, compared with the Breadth Maximum of spacer assembly 3002, by framework in this technique Magnet 10340 in 3310 underarm 10330 is further separated.This positioning and position are easier patient 1000 will Headband folder 10210 is attached to the underarm 10330 of framework 3310 or takes off headband folder 10210 from the underarm 10330 of framework 3310 From.It is set more closely to be alignd with Frankfort horizontal direction and therefore without collection in addition, improving following belt tension vector LV In in the case of specific facial zone, headband tension force is more equally distributed in patient facial region.This also improves mask 1000 Stability.

Mask, headband folder is magnetically engaged with the magnet in shell.When headband is pressed from both sides and the magnet magnetic in shell Property it can not rotate when engaging because the protuberance stretched out from shell passes through the space being limited in headband folder to protrude, The space also head of a quilt counterband tape is used so that annular passes through.On the contrary, when headband presss from both sides the underarm 10330 of 10210 and framework 3310 In 10340 magnetic engagement of magnet when, the headband folder of this technology 10210 can be rotated by 360 °.Due to the difference of patient 1000 Face and head shape and size, for nose cup headband press from both sides 10210 rotation improve comfortableness and stability.If Patient moves while sleeping soundly, and the possibility of the accidental disengaging of headband folder 10210 can also be reduced, because if headband is pressed from both sides Headband folder can rotate when moving different directions to.In addition,The protuberance of the shell of mask and triangular shaped head Band, which presss from both sides to depart from headband folder from shell, becomes difficult, because this needs patient to be lifted up first or tilt head band press from both sides to disappear Except protuberance.On the contrary, the headband folder 10210 of this technology is by being maintained at the machinery with close cross bar 10218 that headband presss from both sides 10210 Outside twist motion on the relative end of holding member 10215 can depart from from underarm 10330 and make the He of magnet 10340 Magnet 10216 departs from.

The width ratio in the space 10217 in the headband folder 10210 of this technologyWidth in the headband folder of mask is extremely It is few wide twice.When adjusting headband folder length, it means that the positioning of this technology and the bottom head strap band of rock-steady structure 3300 10220 can relatively easily move across space 10217, due toMask is compared, in headband band 10220 and head With folder 10210 between there is less friction and more spaces.This does not come from patient 1000 and does not pass through headband folder 10210 it is smooth and the headband band 10220 that moves freely it is a large amount of it is frustrated in the case of, patient 1000 can be made quick and side Just the headband tension force of patient interface 3000 is adjusted to reach optimum reelability quality and stability.

During treating, the head of patient can gyrate or be rotated during sleeping.When he falls asleep, for by patient 1000 patient interfaces 3000 used, tape and sealing arrangement should also accommodate unconscious or reflexive head and body is moved It is dynamic.If it is not, treatment is just had a greatly reduced quality and makes the patient 1000 by the offer service of patient interface 3000 sick.Can be with Fasten simultaneously or release magnet 10216 and magnet 10340.Due to magnet 10216 and the complementary magnetic coupled surface of magnet 10340 Substantially identical size, therefore start to contact and therefore for initial contact with after once magnet 10216 and magnet 10340 When continued access is closed substantially free from external assistance is needed, they will start substantial automatic aligning.Due to magnet 10216 and magnet 10340 coupled surface has relative or complementary poles and because magnetic couplings surface is generally being substantially normal to or hung down It is straight on the direction of coupled surface being that most strong therefore mutual side suction is relatively weak and can be by the He of magnet 10216 The layback of magnet 10340 makes the side displacement of magnet 10216 and magnet 10340 relatively easily occur, when applying side draw, magnet 10216 and magnet 10340 fastener can be caused to be not intended to or accidental disengaging.Therefore in order to hinder undesirable sidesway, for Headband folder 10210 provides mechanical holding member 10215.By the way that headband folder 10210 and underarm 10331 are pulled open, make them simple Separate and be moved away from each other.When magnet 10216 and magnet 10340 closer to each other, they are by automatic fastening.

It is that magnet 10216 and magnet 10340 are packed and are preferably waterproof completely or airtight, to minimize or eliminate Magnet 10216 and magnet 10340 can cause the possibility for the oxidation or corrosion demagnetized or deteriorated.Magnet 10216 and magnet 10340 packaging provides ornamental covering, to protect magnet 10216 and magnet 10340 away from environment and ensure that they are protected Hold initial vision to attract, it is important for product recommendations and product appearance that the vision, which attracts,.In instances, magnet 10216 Coating (magnet 10216 and magnet 10340 that such as, are coated with nickel or zinc) can be included with magnet 10340, such as, to prevent Scraping/damage to magnet.

In an example of this technology, completely adjustable (the upper band 10220 of headband band 3301 of multiple length is used With lower band 10230), to adapt to a variety of head sizes of patient 1000.Patient 1000 often can tense band more than 3301 Some are drawn with attempting to offset that typically unconsciously their head is vacillated now to the left, now to the right or teetered during sleep by patient 1000 The revolving force risen.Some existing magnetic clasps unrelated with the patient interface for continuous positive airway pressure (CPAP) are not set Count into the amount for offsetting the revolving force met with by the patient 1000 moved with unconscious head.In addition, can not be by prior art Some headband bands of mask fully tense to meet all patients 1000.However, in this technique, together with multiple headbands The magnetic underarm 10330 that band 3301 is used, magnetic head band folder 10210 is completely adjustable to meet a variety of of patient 1000 The head of size and can offsetting unconsciously is vacillated now to the left, now to the right their head or caused by teetering by patient 1000 Revolving force.In instances, two band sizes can be provided to provide wide headband fitting limit to cover nearly all patient. It should be noted however that bigger or smaller band size is also possible.

In optional example, upper arm 10320, which can be included at upper head band tie point 10325, to be packaged in or is embedded in Magnet in the distal end of arm 10,320 10323.

6.3.7 blow vent 3400

In one form, patient interface 3000 can include be configured to and be positioned to allow for exhalation air (including exhalation Carbon dioxide) discharge blow vent 3400.The guiding discharge gas of blow vent 3400 is away from framework 3310.

With reference to Figure 78, multiple very small holes 3405 are included (such as according to a kind of form of the blow vent 3400 of this technology Referring to accompanying drawing 106 and accompanying drawing 114), in other words, porous blow vent.It can be set on framework 3310 two or more porous Blow vent 3400.

In instances, discharge blow vent 3400 is integrally formed into framework 3310 and is embodied as at least 30 passages Array, such as at least 40 passages 3405, they surround the tubulature sheathed catheter 10610 of adjacent connectivity port 3600.Change sentence Talk about, discharge blow vent 3400 has substantial rounded shape.That is, ring 10315, which has, surrounds connectivity port 3600 Radial arrangement is to be connected to the porous blow vent 3400 of air loop.Each passage 3405 is set to be shaped so that discharge air expands Dissipate (i.e. non-directional) thus reduce exhaust noise and " air injection " effect, while the enough CO2 emissions of offer. The sleep that the blow vent 3400 of this diffusion attempts to minimize to patient 1000 and their bed companion is bothered.When removal spacer assembly When 30221, the framework side that can enter dead-space volume is cleaned.It therefore, it can clean passage 3405 from both sides.

Blow vent 3400 has 0.317 square millimeter of hole area, 2.9 millimeters of entrance blow vent gap and choma of ventilating Diameter be 34.7 millimeters.If blow vent 3400 has 60 holes and the flow at 20cm water columns is 59 liters per minute. If blow vent 3400 has 41 holes and the flow at 20cm water columns is 45 liters per minute.

The angle of the air-flow of diffusion can be adjusted by changing the size of passage.The air-flow of diffusion is in more large area Exhaust is provided to avoid spraying and noise can also be reduced.The track separated can close on each passage.Track is substantially On be rectangle.However, track can have other suitable shapes such as ellipse with the gas of directing exhaust.In example In, the arrangement of track also includes the use of ring-shaped baffle.

For example, as shown in Figure 106,111,113 and 114, the ring 10315 of framework 3310 includes the He of outer radial wall 10350 Interior radial wall 10351, both of which is protruded backward along connectivity port 3600.Radial wall 10350 and 10351 defines an access to lead to The radial passage of stomata 3405.As described above, the track 10355 separated is extended radially inwardly from outer radial wall 10350 So that exhalation air is directed into passage 3405 from patient.

In instances, can by it is mechanical interlocked the sheathed catheter 10610 of pipe 4180 is connected and (such as good and all connected) arrive The ring 10315 of framework 3310.For example, as shown in Figure 106,107 and 108, sheathed catheter 10610 includes being configured to receive setting To the annular recess or recess 10611 (such as, referring to Figure 14) of the annular rib 10360 of interior radial wall 10351, this allows conduit Set 10610 is mechanical interlocked with interior radial wall 10351.As described, at least one inner surface of recess 10611 can include Oblique structure, such as in favor of interlocking, molding.As shown in Figure 106 and 114, interior radial wall 10351 includes what is extended radially inwardly Stop surface 10353, it is provided with stop surface to prevent pipe sleeve 10610 to be further inserted on framework.In addition, stop surface 10353 is set There is the sign of sheathed catheter 10610, and therefore conduit 4180 is attached to framework 3310 completely.In instances, sheathed catheter 10610 leads to Cross the ring 10315 that interior radial wall 10351 is non-rotatably connected to framework 3310.

In instances, the sheathed catheter 10610 of conduit 4180 can be molded into the insert of framework 3310 to provide forever Ground and non-rotatable connection.Alternatively, mechanical interlocked can be one kind buckle between sheathed catheter 10610 and framework 3310 The mode of cooperation.

In use, as shown in Figure 106, interior radial wall 10351 protrudes to play a part of baffle plate and by logical backward Gas port 3400 separate the flow path of the compressed air for coming from PAP equipment of arrival and exhaust flow path with reduce follow Ring noise.In instances, sheathed catheter 10610 can protrude so that by inlet air flow path, (PAP that comes from of arrival is set backward Standby 4000 compressed air and the exhalation air for coming from patient) and interior radial wall 10351 isolate.

6.3.8 connectivity port 3600

Connectivity port 3600 allows the tubulature 4180 that patient interface 3000 is connected to air loop 4170, such as Figure 83 institutes Show.In an example of this technology, tubulature 4180 can be connected to by patient interface 3000 by connectivity port 3600. Can be at connectivity port 3600 by the way that framework 3310 is insert molded on tubulature 4180, short set is especially insert molded Tubulature 4180 is connected to framework 3310 on pipe sheathed catheter 10610.Connectivity port 3600 can be located on patient interface 3000 And it can provide to the fixed or movable connection of gas delivery conduit 4180.

Connectivity port 3360 can be a part for framework 3310 so that framework 3310 is molded including the company of one Connect port 3600.Furthermore, it is possible to which connectivity port 3600 is connected into framework at the finite part or some on its periphery 3100, this, which may result in the open area between connectivity port 3600 and framework 3100 and these open areas, to include Blow vent 3400 described herein.Connectivity port 3600 can be at an angle of in any direction and opposing frame 3310 is into random angle Degree.Connectivity port 3600 can be formed down angle to meet most of patient during treating typically with opposing frame 3310 Make the need for conduit 4180 is directed downwardly toward.This minimizes the circulation of conduit 4180 and can improve patient interface during treatment 3000 sealing and stability.It is also possible to connectivity port 3600 that shape separates with framework 3310 and connects these parts so that Can rotate the opposing frame 3310 of connectivity port 3600 using connection is turned round.In such instances, reduction interference can be improved The pipe moment of torsion of the tubulature 4180 of sealing force, or if tubulature 4180 is constructed to the tubular type position on patients head (tube-up position) is to improve comfort level and sealing.

It should be understood that the air-flow into patient interface 3000 can be more equally distributed in the example of this technology, Air loop 4170 is wherein connected to patient interface 3000 without using bend pipe.The sharp bending of bend pipe can cause bend pipe side Upper big streamline density.This can induce injection, flow compressed and this can cause less preferably to flow into patient here Interface 3000, and specifically, structure 3100 is formed into sealing.It should also be understood that the ventilating opening 3400 of foregoing description It can aid in reduction injection.It is existing by allowing to rotate against movement at least between air loop 4170 and framework 3310 The use for having bend pipe in mask decouples pipe moment of torsion, and a kind of form of this technology has especially soft tubulature 4180, its energy The responsible pipe moment of torsion of enough traditional bend pipes of decoupling.

6.3.9 forehead support

In a kind of form of this technology, patient interface 3000 does not include forehead support.In one form, it is not necessary to The patient interface 3000 of forehead support provides sufficient stability, and this can cause less mandatory contact and open double Eye and nasal bone.

In one kind deformation, patient interface 3000 includes forehead support.

6.3.10 anti-suffocation

In a kind of form of this technology, patient interface 3000 can include anti-suffocation valve (AAV).It is further in this technology Example in, when using foil facial mask when, AAV can be included in decoupling-structure 4190 (referring to Fig. 1 b), air loop 4170 (referring to Fig. 1 a to Fig. 1 c) or patient interface 3000.

6.3.11 port

In a kind of form of this technology, patient interface 3000 can include one or more supply oxygen gas ports 4185, Its space allowed access into pumping chamber 3200.In one form, it is allowed to clinician's supply supply oxygen.In a kind of form In, it is allowed to direct measurement, such as pressure are carried out to the characteristic gas in pumping chamber 3200.

6.4 decoupling-structures 4190

In one form, patient interface 3000 includes at least one decoupling-structure, for example, the sheathed catheter of rotation or suitable Orchestration 4190, as shown in Fig. 1 b and Fig. 1 c, or ball-and-socket.With reference to Fig. 1 b and Fig. 1 c, pass through at least part of tubulature 4180 Ground provides the decoupling of pipe drag force.By means of which, at least part of tubulature 4180 serves the work of decoupling-structure 4190 With.

With reference to Fig. 1 b and Fig. 1 c, the end of tubulature for rotation sheathed catheter or adapter 4190 in favor of connection To the additional gas delivery conduit 4178 for being different from tubulature 4180 at least one aspect.Rotatable sheathed catheter allows short-range missile Pipe 4180 and additional gas delivery conduit 4178 rotate relative to one another in respective end.Additional gas delivery conduit 4178 can With comprising the feature similar to tubulature 4180, but there can be bigger internal diameter (such as 18 millimeters to 22 millimeters).There is provided This additional free degree to pipe can be by alleviating the torsion of air loop 4170 or kinking to help to reduce thus Pipe drag force.The other end of additional gas delivery conduit 4178 may be coupled to PAP equipment 4000.

6.4.1 tubulature 4180

In a kind of form of this technology, led at connectivity port 3600 by being connected to the longer of PAP equipment 4000 Tubulature 4180 is connected to framework 3310 by pipe (additional gas delivery conduit) 4178, as shown in Figure 82.The shape of tubulature 4180 Into partial air loop 4170.

Tubulature 4180 is the gas delivery conduit according to this technology one side, and it is constructed and arranged to allow PAP to set The flowing of standby air flow or breathable gas between 4000 and patient interface 3000.

Gas delivery conduit is through managed drag force, and it represents the power being subjected to when pipe is used, and the pipe is pulled during use Power is applied on patient and other surfaces (such as bed, bedside cupboard, sick bed, desk and floor etc.).Due to tubulature 4180 being connected Patient interface 3000 is connected to provide respirable gas to patient 1000, these pipe drag forces can cause influence patient interface Connection between 3000 and patient.For example, tension pipe drag force and torque tube drag force can cause patient interface 3000 from trouble Person's face is removed.Thus cause from patient interface 3000 and reveal breathable gas.Therefore, it is desirable to reduce pipe drag force. This can realize that improving its flexibility (such as by reducing bending radius, can make by reducing the weight of tubulature 4180 Pipe 4180 is closely bent), and increase at least one degree of freedom for tubulature 4180.In addition, not significantly decreasing The reduction of this pipe drag force must be realized in the case of the intensity of pipe 4180, such as when patient can be by his or her arm When being placed on pipe 4180 or being torqued into the position kinked, it is set to resist snap-in force.

Fig. 4 to Fig. 6 shows three side views of the exemplary tubulature 4180 in three kinds of different conditions.Fig. 4 is shown Tubulature 4180 in nature or usual condition.In its natural state, tubulature 4180 does not suffer from any extra Power, that is to say, that it is not extended or compressed.Tubulature 4180 can be made up of web material 4172, and web material 4172 is in spiral shell It will be separated between the adjacent windings of spin line circle 4174.The spiral winding 4174 of tubulature 4180 can have WC width.Material Expect that net 4172 can be across the distance between adjacent windings WF.Further, as shown in figure 4, can with folding material net 4172, So that the summit of folding part 4182 or peak dot extend radially outwardly between adjacent windings.It should be understood that due to web material 4172 folding part 4182, including the width of the material of web material 4172 can be wider than the width between adjacent windings WF.In addition, Can be along the predetermined folding material net 4172 of broken line 4186.

Or as shown in figure 4, when tubulature 4180 in the raw when, the distance between adjacent windings WF can be with spiral shell Spin line circle WC width is equal or substantially equal.In this set, the maximum curved of catheter tube 4180 is reduced Bilge radius R (as Fig. 7 is shown) and improve flexibility.Because necessary more than the material of the quantity of pipe in the prior art For across the distance between adjacent windings.For example, W causes substantial amounts of material horizontal apart from F is identical with coil WC width Across this distance, because it is to fold, it is therefore necessary to provide even greater number of material with including web material 4172.Fig. 7 This principle is described in more detail.The shape of folding part 4182 is critically important for the overall flexibility of conduit 4180. The bigger radius of the folding part 4182 of net produces more flexible pipe and leads 4180.Obvious folding line makes conduit 4180 lack flexible Property.After multiple heat sterilizations circulation, folding part 4182 starts relaxation and opened and conduit 4180 becomes do not have pliability more.Work as folding When portion relaxes, the diameter opposed coil diameter that folding part can be observed reduces and therefore reduces the peak dot of folding part 4182 4186。

In addition, in fig. 4, it is seen that the folding part of web material 4172 not only extends radially outwardly from tubulature 4180, And make center of the folding part of web material 4172 between the adjacent windings of spiral winding 4174.In addition, Fig. 4 also show How the rake of web material 4172 increases from the adjacent windings of spiral winding 4174 towards the summit of folding part 4182 or peak dot. In other words, web material 4172 is more flat away from predetermined broken line or peak dot 4186, top of the web material 4172 in folding part 4182 It is more precipitous and sharper that point or peak dot 4186 nearby become.

Still in Fig. 4, it will will be described in detail below, it can be seen that the outside or outer surface 4184 of spiral winding 4174 Profile with bending, the profile is circular in wide angular range.In other words, spiral winding 4174 can have ellipse The profile of circular a part of circumference., can be to trouble by providing rounded outer surface or profile 4184 to spiral winding 4174 Person 1000 provides softer more smooth touch perception.In addition, this rounded outer surface 4184 can also reduce tubulature 4180 tendencies become entangled in when it is used on such as clothes of bed, patient, bedroom or hospital furniture.As in Fig. 4 Seen, it can be seen that coil diameter DC, diameter DC is perpendicular to multiple spiral windings of the longitudinal axis measurement of tubulature 4180 The diameter of one in 4174.

Can with it is seen from figure 4 that another be characterized in that tubulature 4180 in its natural state has from gas conveying The folding part 4182 for the web material 4172 that conduit 4180 is projected radially outward so that the summit of folding part 4182 or peak dot are in Substantially the same height, or it is identical with the height of the outer surface 4184 of spiral winding 4174.The folding part of web material 4172 4182 further define the collapsed diameter DF between the opposed apexes of the folding part 4182 of the longitudinal axis measurement of tubulature 4180. In another way, when tubulature 4180 in its relaxed state when, across the folding part 4182 of the tubulature 4180 each top Point web material 4172 diameter can be with the spiral winding 4174 of the leap longitudinal axis across respective outer surface 4184 diameter phase Deng, wherein folding part 4182 across gas delivery conduit 4180 the longitudinal axis.It can describe, if by tubulature 4180 certainly When distorting placement under right state, then single cylinder can be defined to be flush to summit or peak dot and the spiral shell of folding part 4182 The outer surface 4184 of spin line circle 4174.Furthermore, it is possible to describe, when tubulature 4180 in the raw when, folding part is straight Footpath DF is equal with coil diameter DC or is substantially equal.

Improved touch perception can be provided with reference to the arrangement of the rounded outer profiles 4184 of spiral winding 4174, is carried to patient For more smooth and soft sensation.Further, it is also possible to by making summit or peak dot and the spiral winding 4174 of folding part 4183 Outer surface 4184 rises to identical height to strengthen the tendency that reduction tubulature 4180 tangles, because notable without single surface Ground protrusion is to tangle on the outer surface.

, can be between the adjacent windings of spiral winding 4174 by web material 4172 in another example of this technology Repeatedly fold.Due to the material of the extra quantity between each adjacent windings, this can allow the extra of tubulature 4180 Pliability and further ductility.In addition, in this technology another example, along web material 4172 spiral winding phase The length of the tubulature 4180 folded between adjacent line circle and other regions of the not folded gas delivery conduit of web material are present Specific region or part.This arrangement can allow along the different degrees of pliability of gas delivery conduit length and extending Property.For example, can be provided at the position close to patient interface 3000 and PAP equipment 4000 hard with what is be continuously increased or reduce The part of the tubulature 4180 of degree.In an example, close to patient interface 3000 and the tubulature 4180 of PAP equipment 4000 Part can have less folding part on every element length of conduit 4180 increase the conduit 4180 in these regions Hardness kinks to ensure to reduce in these regions.Another allow web material 4172 it is a part of not folded the reason for be system The reasons why making.For example, not having folding part 4182 on net 4172 in far-end, wherein wrapping sheathed catheter 10610,4190 Cover shaping.This can reduce the trend that weakness (weak spot) is produced in net 4172, wherein at these positions, making conduit The engagement of set 10610 and 4190 can be bound for folded net in weak impaction state.

Fig. 5 shows another side view of exemplary tubulature 4180.In this view, tubulature 4180 is in pressure Contracting or contraction state.In a state, the length of tubulature 4180 is less than its length in nature as shown in Figure 4 Degree.For example, tubulature 4180 can be compressed to during less than nature 50% length.When tubulature 4180 is compressed into it During compressive state, web material 4172 is compressed to this degree：Its folding part 4182 becomes precipitous and spiral winding 4174 The distance between adjacent windings WF is reduced.In compressive state, the distance between adjacent windings WF can be reduced to less than spiral shell Spin line circle WC width.Furthermore, it is possible to force the folding part 4182 of web material 4172 summit or peak dot 4186 in radial direction On further out so that summit or peak dot projection above the outer surface 4184 of spiral winding 4174.In other words, material Net 4172 can become higher.Can be by the quantity and the angle and web material of folding part of the material between adjacent windings WF 4172 TW thickness controls this effect.Further, it is understood that when spiral winding WC width is in compression tubulature When cannot be reduced during 4180, just as common for other springs, the adjacent of spiral winding 4174 can be forced Coil flocks together.Or in Fig. 5, it can be seen that when tubulature 4180 is in compressive state, in the folding of web material 4172 Angle at the summit in folded portion 4182 or peak dot 4186 is (that is, the web material 4172 on the side of predetermined broken line Each part between angle) reduce, also, again, web material 4172 can become higher.

Fig. 6 shows the additional side view when tubulature 4180 is in its extension or elongation state.In a state, Tubulature 4180 can have the long length of length when under the nature shown in Fig. 4 than it.For example, can be by short-range missile The 200% of its length that pipe 4180 is extended in nature.In addition, in this view, it can be seen that spiral winding The distance between 4174 adjacent windings WF is added, and the folding part 4182 of web material 4172 becomes more flat.In addition, adjacent The distance between coil WF can increase to greater than spiral winding WC width.Further, in fig. 6 it can be seen that can be with Force the folding part 4182 of web material 4172 summit or peak dot 4186 radially outward so that summit or peak dot drop below spiral shell The height of the outer surface 4184 of spin line circle 4174.Furthermore, it is possible to quantity and folding part by the material between adjacent windings WF 4182 angle controls this point.Further, it is understood that when spiral winding WC width tubulature 4180 extension When period does not increase, just as common for other springs, the adjacent windings of spiral winding 4174 can be forced to separate Open.Or in. fig. 6, it can be seen that, when tubulature 4180 is in extension state, the top in the folding part 4182 of web material 4172 Angle at point or peak dot 4186 is (that is, each part of web material 4172 on the either side of predetermined broken line Between angle) add, also, again, web material 4172 can become more flat.

Fig. 7 shows the exemplary tubulature 4180 bent between the two ends.When bending as shown in Figure 7, Web material 4172 between the adjacent windings of spiral winding 4174 can extend in the outside of bent portion 4179, and 4176 inside portion office compression material net can bent.When bending to this appearance, bending half can be better understood from Footpath R limitation.In an example, when conduit covers the cylinder with 13 millimeters of diameter, conduit under its Gravitative Loads ( That is without under the weight additionally applied) there can be 44 millimeters of radius of curvature R.Material comprising web material 4172 Quantity is more, and radius of curvature R may be just smaller, as shown in Figure 7, and the outside of bent portion 4179 can extend only into adjacent The distance of maximum possible between coil WF.In the outside of bending 4179, tubulature 4180 can be only curved at outside 4179 Width bent and that the web material 4172 provided between adjacent windings WF is provided.Therefore, if to adjacent windings WF it Between web material 4172 more materials are provided, then improve pliability, because can bend tubulature 4180, this causes curved The outside of song 4179 further extends and reduces maximum deflection radius R.

Further, it can be seen that the distance at the inner side inside the bending of bending 4176 between adjacent windings WF reduces spiral shell The adjacent windings WF of spin line circle 4174 almost in contact with point.Therefore, radius of curvature R also at the inside of bending 4176 by limiting System.As can be seen in Figure 8, at the inside of bending 4176, the staypak between the adjacent windings of spiral winding 4174 Expect net 4172.Therefore, web material 4172 is thicker, and maximum deflection radius R is also bigger, because material quantity is got between adjacent windings WF Many, then adjacent windings can be also lower close to mutual degree at the inside of bending 4176.

Therefore, in order to optimize the radius of curvature R of tubulature 4180, it is necessary to provide enough width to permit to web material 4172 Perhaps the outside extension of bending 4179, so as to meet desired bending radius, and can provide enough thickness to web material 4172 Spend to allow the adjacent windings WF of spiral winding 4174 to be combined at the inside of bending 4176 to obtain desired bending Radius.

Fig. 8 shows the viewgraph of cross-section of exemplary tubulature 4180 as shown in Figure 7.Tubulature 4180 this Viewgraph of cross-section shows the gas delivery conduit 4180 under nature so that the distance between adjacent windings WF and spiral Coil WC width is identical.Tubulature 4180 can have about 18 millimeters of internal diameter DI.Tubulature 4180 can have 3.2 millis Rice is to the spacing P between 4.7 millimeters, or preferably 4.5mm to 4.7mm.This view also show spiral winding 4174 can With with thickness bigger the thickness TW than web material 4172.In the case where spiral winding 4174 is thicker than web material 4172, Spiral winding 4174 can provide structural strength and this give the spring effect of tubulature 4180.Or in this view, It can be seen that web material 4172 can have substantial as one man and/or continuously thickness.

Fig. 8, which also show at least material part material net 4172, to be asymmetrical on predetermined broken line 4186.For example, Net materials 4127 can be included in the protrusion of the adjoining spiral winding 4174 on the side of predetermined broken line 4186 and can be wrapped Include the rake 4183 on the adjacent opposite side of spiral winding 4174.In addition, summit or peak dot of the web material 4172 to folding part 4182 gradient is steeper than on the side of protrusion 4181 on the side of rake 4183.Due to different steepness, when short Conduit 4180 in nature, the edge of the spiral winding 4174 on the side of rake 4183 and predetermined broken line 4186 it Between width WFS can be less than between the edge of spiral winding 4174 on the side of protrusion 4181 and predetermined broken line Width WFF.Therefore, when web material 4172 extends, can extend to web material 4172 so that WFS than WFF increase it is more, Because substantial amounts of material is included in that region.In other words, tubulature 4180 can be extended specific in a first direction Amount (for example, from rake 4183 to protrusion 4181) and in a second direction opposite the first direction by tubulature The different amount (for example, from protrusion to rake) of 4180 extensions.This arrangement can be beneficial, wherein patient interface 3000 Tubulature 4180 is attached at one end and PAP equipment 4000 is attached in the other end, because patient 1000 can wear Moved while patient interface 3000, therefore bigger extensible extent on the direction of patient 1000 is necessary.Conduit 4180 Asymmetric profile is the result for typically how manufacturing conduit 4180.Alternatively, for even for web material 4172, with pass In the profile of the virtual symmetry of predetermined broken line 4186 be possible.

As seen in fig. 8, protrusion WH width can be different from rake WS width.Therefore, web material 4172 can be more wider than being bent across protrusion 4181 across rake 4183 towards adjacent windings WF.In other words, by In the larger gap at WS, the flexibilities more a greater amount of than at the WH with small gap are there may be in this specific region (that is, smaller bending radius).In addition, because of the less gap at WH, this part can be more compressible to more than at WS Small degree because compared with WS at WH web material 4172 closer to coil 4174.

Figure 8 illustrates another be characterized in shallow surface area (for example, the outmost surface face of short tube 4180 Product) it can be included compared with web material 4172 by the outer surface 4184 of spiral winding 4174 with larger proportion, if helix Circle 4174 normally feels more preferable than net 4172, if the folding part especially in net 4172 is very sharp.This can be trouble Person provides more preferable tactile sensation, because as that can see in fig. 8, the outer surface 4184 of spiral winding 4174 is circular And therefore than web material 4172 folding part 4182 summit or peak dot it is smoother.

In addition, it can be seen in fig. 8 that web material 4172 can be combined integratedly with spiral winding 4174 so that short-range missile The inner surface of pipe 4180 is smooth and continuous.It should be understood that any sides adjacent of web material 4172 can be joined to each other Smoothly the adjacent of the adjacent windings of spiral winding 4174 is can be incorporated into be formed with continuous inner surface or web material 4172 Side.By forming tubulature 4180 in this way so that smoothly with continuously, gas delivery conduit can be passed through during inner surface 4180 provide the more stably flowing of breathable gas.Generally, the overmolded sheathed catheter on the two ends of tubulature 4180 10610th, 4190 form folding part 4182 later to prevent band from clamping.

It should be understood that any appropriate combination of material can include web material 4172 and spiral winding 4174.Each phase Answer part 4172,4174 material can with it is identical or they can be at least different in one aspect.In a reality of this technology In example, web material 4172 can be made with spiral winding 4174 by thermoplastic elastic part (TPE) or thermoplastic polyurethane (TPU) Into.Net 4172 can be made up from coil 4174 of identical plastic material (or different mixing of same plastic material), its It is favourable for producing overall chemical key (molecule adhesion) between net 4172 and coil 4174.Limited by Multiple factors Material is selected.The mechanical property of web material 4172 for allowing flexibility is determinant.The ability for being subjected to heat sterilization is another Individual key factor.It is other factorses not glue with viscosity.In addition, when external force is applied on the circumferential surface of conduit 4180 tubulature 4180 must avoid occlusion and be subjected to hoop stress, if limbs of patient is placed on the upper end of tubulature 4180, so this may send out It is raw.This is solved by providing the tubulature 4180 with minimum diameter, and the pitch and knot of concrete regulation spiral winding 4174 Structure rigidity.

The selection of material can also affect on tubulature 4180 spring rate (P=kx, wherein P are load, k be rigidity simultaneously And x is deflection).Elasticity sees that more rigid deflection is smaller under permanent load.Spring speed is for making the spring of every measuring unit The quantity of weight needed for (any spring) deflection.For example, the material with dual extension-compression modulus and differently curved rigidity can be with Web material 4172 and spiral winding 4174 are respectively used for, to form desired spring rate.Similarly, for web material 4172 With for spiral winding 4174 spring rate can also be selected by using the material with same elastic modulus.In addition, as joined Pitch according to Fig. 8 spiral windings 4174 described can also influence the resilient stiff of gas delivery conduit 4180.In an example In, spring rate may be about 0.03N/mm.

Fig. 9 shows another view of the exemplary tubulature 4180 in bending or case of bending.In this view, Similar with Fig. 7, tubulature 4180 is bent on radius R.However, tubulature 4180 can be considered as covering flat in this view Above face, the edge of elevation surface (such as desk), with show when due to gravity at one end by tension force when conduit 4180 can be with How to bend.The weight of a part for the tubulature 4180 being suspended on above the corner of desk may cause to the extension of conduit 4180 And the bending in the region of the conduit 4180 near edge of table.This view description with show in Fig. 7 these are similar Bending features.Specifically, web material 4172 extends in the outside of bending area 4179 and in the inside of bending 4176 pressure Tightly so that be more than in the WF of curved outer on internally.

Figure 82 shows the exemplary tubulature 4180 for being attached directly to patient interface 3000.In existing mask, gas Body delivery catheter is attached to mask by swivel elbow.By being drawn again by swivel elbow with the intersection of patient interface at it Conductive gas delivery catheter, prior art component attempts to reduce pipe drag force.However, weight that swivel elbow increase can include and portion Point, this may then mitigate the reduction of pipe drag force.Therefore, according to this technology, tubulature 4180 can be connected directly to face Cover framework 3310.Tubulature 4180 can be down at an angle of from the connection with mask frame 3310, and this can also promote to reduce The drag force of pipe.Downward angle can partly be promoted by connectivity port 3600.

Referring again to Fig. 1 b and Fig. 1 c, according to the tubulature 4180 of this technology it can be seen that being connect in first end connection patient Mouth 3000.This connection can be being fixedly connected for above-mentioned reference picture 82.In this example, sheathed catheter 10610 is overmolded onto In the first end of pipe 4180, conduit is then overmolded to the corresponding connectivity port 3600 being limited in patient interface 3000. This example is no bend pipe in the sense that not having bend pipe between conduit 4180 and mask frame 3310.In other examples, can Energy is that swivel elbow is positioned between conduit 4180 and mask frame 3310 so that swivel elbow and conduit 4180 are relative to face Cover framework 3310 is rotated freely through.It should be understood that the patient interface 3000 shown in these views be shown with dashed lines with Indicate that a variety of different patient interfaces may be coupled to tubulature 4180.It is rotatable conduit at the second end of tubulature 4180 Set, rotary guide pipe set or adapter 4190 are possibly connected to the other gas delivery conduits different from tubulature 4180 to facilitate 4178 the 3rd end (referring to Figure 36 and Figure 82).Rotatable sheathed catheter 4190 allows tubulature 4180 and other gas delivery conduits 4178 rotate in respective end relative to each other.Tubulature 4180 provide a body canal, rotary body 4190 provide 360 ° not by Resistance moves only to adapt to substantially any sleeping posture.

Other gas delivery conduits 4178 can include the feature similar with tubulature 4180, but can have bigger Internal diameter (for example, 18mm -22mm).There is provided this other free degree of conduit 4178,4180 can be passed through by alleviating winding, decoupling Any pipe drag force for receiving and the thus kink of tubulature 4180 help to reduce pipe drag force.Other gas delivery conduits 4178 the 4th end may be coupled to PAP equipment 4000.Two parts rotary body of engaging is that shaping is assembled in sheathed catheter 4190. Alternatively, a part of rotary body in engaging is possible.

Reference picture 10- Figure 29, the conduit 4180 of this technology and the tubulature of the prior art with spiral winding are contrasted.This Contrast shows that the bending rigidity or flexibility of the conduit 4180 of this technology are remarkable, because it has when conduit 4180 deploys Relatively low gram force (gf).The lower end of conduit is maintained at fixed position so that the longitudinal axis of conduit is from the direction perpendicular to applying power Angle starts to extend tubulature.In other words, the lower end of tubulature be retained as so that its initially parallel, horizontal surface and With horizontal surface tangent (referring to Figure 10, Figure 15, Figure 20, Figure 25).The upper end of tubulature passes through Instron device (Instron Machine above the holding lower end for) being directly maintained at tubulature.Instron device is with one along direction straight up Arrange the distance that tubulature is extended to 30mm from 0 to 30mm, to 60mm, to 90mm with the step to 120mm.Instron device Newton force can also measured at each distance corresponding with the spring rate of tubulature.Torque meter (turns with power meter Square meter RMNo.MTSD05997 and Mecmesin power meters RMNo, MFGX05996) it be used to be extended in tubulature Each distance at measurement the fixation lower end of tubulature gram force.Because conduit has different weight and length, therefore first Instron device, torque indicator and power table are returned to zero at beginning position.By the measurement apparatus that returns to zero in this way, measurement may be solely Stand on the weight and length of each conduit.1cm grids also are disposed in background generally to indicate the tubulature at each distance Angle.This contrast is shown：

Comparison above shows that the tubulature 4180 of this technology only starts to undergo the conduit turn extended between 30mm and 60mm Square, and prior art conduit has been subjected to the conduit torque of 30mm extensions.At each distance of measurement, the conduit with this technology 4180 compare, and prior art conduit, which has, represents their significant more Gao Ke less soft and with higher bending stiffness Power.With the conduit of prior art, because conduit 4180 can not possibly occur for torque, therefore sealing interference is also impossible to conduit 4180 occur.In addition, the flexibility of conduit 4180 allow to do not require to be generally used for solve the swivel elbow of conduit torque or Framework 3310 is connected directly in the case of ball-and-socket bend pipe.Reduce this does away with the overall gravity for causing patient interface 3000 Extra section.It is pulled away from any conduit drag motions so that sealing is formed into structure 3100 before patient facial region, due to conduit 4180 Seldom perceived by patient 1000 and it is that patient 1000 provides bigger freedom of movement, therefore which raises comfort level.

As noted previously, as tubulature 4180 is moved relative to patient interface 3000, it can produce conduit drag force.This In conduit drag force can include power and/or torque, but will be understood that unless stated otherwise, otherwise term conduit is dragged Drag includes power and/or torque.

One reason of this conduit drag force can be the bending of tubulature 4180.For example, when patient 1000 is away from PAP equipment 4000 when rotating their body, and the bending formed in tubulature 4180 may form conduit at patient interface 3000 and pull Power, it potentially interferes with sealing, and/or forms uncomfortable to patient.

To show the effect of conduit drag force, it may be considered that the letter including patient interface 3000 Yu the system of tubulature 4180 Change and represent.It can be assumed in such a system, patient interface is arranged on patient 1000, and headband separated from patient interface. In this case, any conduit drag force all must be by the reaction of patient interface 3000, wherein for example any torque can be Power has the opposite effect when combining on patient 1000, and/or any power can be by equal and opposite on patient 1000 Reaction force have the opposite effect.

The conduit drag force formed at patient interface 3000 can be related to the structure of tubulature 4180.More specifically Say, because tubulature 4180 is bending, the bending stiffness of tubulature 4180 can influence what is formed at patient interface 3000 Conduit drag force.

Normally, when the cylindrical conduit object of constant cross-section is fixed on fixing end and is carried in free end (i.e., Cantilever) when, it can be described as in formation power and the torque of fixing end(unrelated gravity), wherein d is deflection, and P is perpendicular Straight power, l is the length of conduit, E be the modulus of elasticity and I of material be the area of cross section the second torque.Here, in fixation The reaction that end is formed is probably the vertical force P and torque lP along relative direction.

This is applied to the system including patient interface 3000 Yu tubulature 4180, can be vertical in the reaction of near-end Power P, and torque lP, it can form a part for conduit drag force.Above formula can be rearranged intoThen for assigned direction d (that is, the torque for being given by patient 1000), and catheter length I, EI is worked as Conduit drag force may increase during increase, or conduit is pulled and may reduced when EI reduces.

For the circular pipe of constant cross-section, it is possible to use formulaTo calculate I.Therefore, As example, for given 15mm internal diameter (di), reduction of the external diameter (do) from 19mm to 18mm may make conduit drag force It is reduced by about 32%.Similarly, although the relation is probably linear, the springform in the material used in this case The reduction of amount can realize the reduction of conduit drag force.

Therefore, although tubulature 4180 in this technique can not be the circular pipe of constant cross-section, short-range missile Total bending stiffness of pipe 4180 can be the geometry of some of tubulature 4180 and the result of material property, such as material Expect net 4172 and spiral winding 4174.

The reduction of structural integrity of tubulature 4180 may be caused by reducing the bending stiffness of tubulature 4180.That is, as Example, if the thickness of web material 4172 by reduce tubulature 4180 external diameter change, then can reduce bending stiffness with And the thus drag force of conduit, but this may cause the more flimsy of tubulature 4180 to construct and cause normally using During tubulature 4180 closing.

Therefore the advantage of this technology is that the geometry of tubulature 4180 and the combination of material are same to reduce bending stiffness When keep appropriate intensity so that avoid occlusion and persistence.

Can not possibly by conduit 4180 be compressed axially with extension occur viscous noise/stiction in the case of, lead Pipe 4180 is substantially noiseless.An example for noise to be reduced or eliminated can apply additive to prevent helix The coil of circle 4174 is adhered to each other.Before noise of the conduit of patient interface by this type is become known for, because it is Uninterrupted noise therefore when attempt during sleep this be probably irritating for patient 1000 and their bed are with 1100.Lead Pipe 4180 be intended to lightweight so that the conduit drag force caused under gravity by the weight of conduit 4180 is minimized.In this technology An example in, in nature, the length of conduit 4180 may be about 285mm including end sheathed catheter 10610,4190 To 305mm and it can weigh about 18.7 grams to 19.1 grams.Therefore, conduit 4180 with end sheathed catheter 10610,4190 Weight may be about 62.6g/m to 65.6g/m.End sheathed catheter in conduit 4180 Yu the overmolded end to conduit 4180 10610th, there is no air leakage between 4190.One end sheathed catheter can be allow tubulature 4180 and long duct 4178 it Between 360 ° of rotary guide pipes sets 4190 for rotating against, and another end sheathed catheter is non-rotary framework sheathed catheter 10610.Rotation Transduction pipe sleeve 4190 can have the forefinger for patient 1000 provide outside tactile periphery edge protuberance so that conduit 4180 and The catheter adapter 4190 for being connected to long duct 4178 is disengaged.From long duct 4178 engage repeatedly be disengaged after Protuberance can tolerate higher power to strengthen the persistence of rotary guide pipe set 4190 and tubulature 4180.

Notwithstanding single spiral winding 4174, it is contemplated that multiple helixes can be provided for conduit 4180 Circle.Multiple spiral windings for conduit 4180 can be many starting points (double starting points, three starting points etc.), in other words more than one spiral shell Line.This can allow each spiral winding to be made from a different material or strengthen with different sizes the softness of conduit 4180 Property, thus reduce conduit drag force but also by prevented with strong structure or impedance kink with occlusion.

6.5 alternative patient interfaces

Reference picture 30 is to Figure 36, and the patient interface 3000 in example in this technique includes frame assembly 3001, pad Component 3003 and positioning and rock-steady structure 3300.Spacer assembly 3003 is removedly engageable with frame assembly 3001.Positioning and Rock-steady structure 3300 is removedly engageable with frame assembly 3001.There is spacer assembly 3003 sealing to form structure 3100 and increasing Pressure chamber 3200.Framework 3310 has the connectivity port 3600 for being used for being connected to air loop 4170.Framework 3310 is provided to fixed Position and the four point attachment of rock-steady structure 3300.

There are three keeping characteristics on the outer surface of pumping chamber 3200, thus its by framework 3310 in pumping chamber 3200 It is held in place in above outer surface.In fig. 33, framework 3310 is provided as upper arm 10320 and underarm 10330 Two pairs of opposing arms 10320,10330.Upper arm 10320 provides a pair of relative upper headband tie points, while underarm 10330 is provided Relative a pair of lower headband tie points 10331.Upper arm 10320 is positioned so as to it with their upper headband tie point 10325 The power provided by top counterband tape 10230 is guided into upward force vector, its provide power with allow patient interface 3000 lead to Cross sealing and form structure 3100 and be sealed on upper lip and cartilage framework (referring to Figure 33).Lower wall 10330 and their lower headband Tie point 10331 is positioned so as to them and following counterband tape 10220 is directed to the downwardly directed force vector for providing reaction force To be rolled up and along any seal break-off power of upward direction on impedance patient's interface 3000 in amount.Which increase mask 3000 Stability and make sealing minimum interference.Reaction force can also provide downward force vector, and this allows suffering from use Increased stability in the upward construction of the conduit of person's interface 3000.

6.4.1.1 Y shape headband connector 800

Reference picture 37 is to Figure 41, in another example of this technology, and two head Belt connectors 156 are operably connected Structure 3100 is formed to sealing.Two head Belt connectors 156 are connected to Y shape headband connector 800, and it is subsequently connected to headband bar Band 10220,10230.Y shape headband connector 800 is guided by headband tension force substantially along parallel to Frankfort horizontal direction The force vector of offer.Provided substantially along the force vector edge in Frankfort direction along perpendicular to Frankfort horizontal direction The power of vertical direction be uniformly distributed.The power being evenly distributed is prevented by the power of headband tensioning offer along up or down Any deflection in direction, thus resists volume or last volume.Increased stability can allow patient interface 3000 stably to use During construction is constructed (in the tubulature 4180 of above-head) and under conduit on conduit.

Patient interface 3000 has spacer assembly 3005, and it includes providing to positioning and the four point attachment of rock-steady structure 3300 A pair of Y shape headband connectors 800.Positioning and rock-steady structure 3300 are connected to pumping chamber via two Y shape headband connectors 800 3200。

Connector can include being suitable to the flange that Y shape headband connector 800 is received in positioning and rock-steady structure 3300 or Interface.It should be understood that Y-connection structure 800 or framework 3310 can be integrally formed with spacer assembly 3005 or Person forms individual components removably to engage with spacer assembly 3005.

The design of Y shape headband connector 800 and the headband tie point being positioned on the arm 10320,10330 of framework 3310 10331st, 10325 its relative positioning with negate or eliminate the need for such a mode of forehead support or vertical headband band will be close Envelope power is directed to sealing area 251.In other words, sealing force is oriented along the substantially parallel direction with Frankfort level.

Y shape headband connector 800 can be positioned at the phase of patient interface 3000 substantially along Frankfort horizontal direction On offside so that Y top extends towards patient ear but terminated before patient ear.Y shape headband connector 800 can Formed with the flexible material by such as silica gel.Each Y shape headband connector 800 has two arms, and it is in spacer assembly 3005 Opposite side on upper headband tie point 810 and following counterband tape tie point 820 are provided.Top counterband tape 10230 and following tape With 10220 tops accordingly along patient ear and lower section extension.Top counterband tape and following counterband tape 10230,10220 with Be connected to neck band 10227 afterwards with formed along behind patients head or rear, along occipital bone, below occipital bone or lower section The circular crown band 10225 of engagement.

6.4.1.2 draw to lead to and prevent feature (pull-through prevention feature) 791

Figure 50 to Figure 52 is returned to, prevents feature is located at from closely leaning on according to a form of drawing of the example of this technology is logical Nearly similar Velcro^TMCovering part or drawing on the following counterband tape 10220 of bindiny mechanism 950, which are led to, prevents feature 791.Following Counterband tape 10220 is connected to the underarm 10330 of framework 3310 so that preventing feature 791 from keeping connection via drawing to lead to.Draw logical prevent Feature 791 is included in close proximity to similar Velcro^TMA part for the following counterband tape 10220 of bindiny mechanism 950, wherein following Counterband tape 10220 is overlapping on themselves and is connected such that to form offer and draw and logical prevents the ring of feature 791.Formed and draw logical Preventing the ring of feature 791 can be compacted to pass through following counterband tape tie point 820 along a direction adaptation so that it allows Following counterband tape 10220 is by preventing following counterband tape 10220 from being drawn along the opposite direction with being disconnected from framework 3310 It is dynamic that framework 3310 is remained connected to by following counterband tape tie point 820.

Only it can prevent the retaining ring of feature 791 will draw to lead to from preventing feature to be pulled through framework 3310 by the way that compression drawing is logical Following counterband tape tie point 820.Following counterband tape 10220 can lead to what is provided by following counterband tape tie point 820 by drawing Hole is connected to the underarm 10330 of framework 3310.Connect below, draw the logical ring for preventing feature 791 to extend to prevent lower headband band 10220 are pulled through to be disengaged with the underarm 10330 of framework 3310 in the opposite direction.

Drawing to lead to prevents feature 791 from preventing headband band to be pulled through following counterband tape tie point 820 and keep lower headband Connection between the underarm 10330 of band 10220 and framework 3310.

The drawing that headband is included on headband band 3301, which is led to, prevents feature 791.Prevent feature 791 logical using sliding drawing to lead to Cross the connection spot hole being present on the headband connector to be connected to after headband connector, drawing to lead to prevents feature 791 from can not lead to Cross and slide back and disconnected with headband connector.Drawing to lead to prevents feature 791 from playing in headband band 3301 and headband The effect of the keeping characteristics of connection is kept between connector.Drawing to lead to prevents feature 791 from can include being present in headband band 3301 End on reinforcement, lap or other structures so that reinforcement, lap or other structures can not be fitted With by the connection spot hole on headband connector, it thus prevent headband band 3301 and be fully pulled through headband connector And disconnected with headband connector.

6.4.1.3 alternative framework 3310

Reference picture 42 to Figure 49, framework 3310 can substantially be formed by rigid material.Framework 3310 can with including increase The spacer assembly 3002 of pressure chamber 3200 is releasably engaged.Engaged by the framework join domain 3312,3313 with framework 3310 Spacer assembly 3002 keeping characteristics 3244,3245, make to engage between framework 3310 and spacer assembly 3002.Framework is connected Region 3312,3313 allows keeping characteristics 3244,3245 to pass through.

Framework 3310 includes the substantially triangular peripheral part 720 with fillet and in peripheral part 720 Connectivity port 3600, to fit in the top of spacer assembly 3002.Peripheral part 720 has the profile with spacer assembly 3002 The crooked outline matched somebody with somebody.Connectivity port 3600 is substantially circular so as to the profile with the front openings of spacer assembly 3002 Match somebody with somebody.Framework 3310 also includes a pair of upper arm 10320 and a pair of underarms 10330.Peripheral part of the upper arm 10320 from framework 3310 720 top extension and the middle position termination substantially between eye and ear.Upper arm 10320 in use Extend in the top of patient's cheek and with crooked outline to be adapted to patient facial region's profile, so that obstacle is minimized.Upper arm 10320 extend downward such that the contact between upper arm 10320 and patient facial region is minimized from patient facial region, so as to avoid not relaxing It is suitable.In other examples, upper arm 10320 is between top extension 80mm to the 100mm of the peripheral part 720 of framework 3310.On Arm 10320 has the upper headgear tie point for the elongate slit form for being used to receive the top counterband tape 10230 passed through 10325.Underarm 10330 has to receive the lower headband of the elongate slit form of the following counterband tape 10220 passed through Tie point 10331.Headband tie point 10325,10331 generates the four point attachment for positioning and rock-steady structure 3300 with even It is connected to framework 3310 and is subsequently connected to spacer assembly 3002.Four point attachment improves the stability of patient interface 3000.On Arm 10320 is generally connected to framework 3310 in the upper frames points 10305 of framework 3310.Single top belt tension vector exists Upper center at upper frames points 10305, prevents sealing from disturbing and energy along parallel to Frankfort horizontal direction Conduit torque of enough operations from air loop 4170.Two lower headband tie points 10331 provide two parallel following belt tensions Vector.

Framework 3310 is provided stability by patient interface 3000 and is made up of colourless clean transparent plastic material.Upper arm 10320 are located at the lower section of patient's cheek and therefore patient interface 3000 unobtrusively and opens the face of patient.

6.4.1.4 the mask with winding pipe assembly 120

Reference picture 30 includes positioning and rock-steady structure to Figure 41 according to the patient interface 3000 of this technology example 3300th, winding pipe assembly 120, air loop 4170 and spacer assembly 3003,3005.Winding pipe assembly 120 has to be included for discharge The blow vent of the exhalation air of titanium dioxide.Positioning and rock-steady structure 3300 may be adapted to support, stable and/or by spacer assembly 3003rd, 3005 it is positioned on patient facial region.

Spacer assembly 3003,3005 may be adapted to be sealingly engaged with the patient airway including patient's nose.Spacer assembly 3003rd, 3005 can receive the breathable gas from air loop 4170 and/or winding pipe assembly 120, and by positioning and Rock-steady structure 3300 is maintained at the appropriate location on patient facial region.

6.6 upper arm sleeve pipes 10312

Reference picture 68, provided with the upper arm sleeve pipe 10312 being made up of woven fabric material.Upper arm sleeve pipe 10312 in use Surrounding can be close to around a part for the upper arm 10320 of patient's cheek.Upper arm sleeve pipe 10312 and upper arm 10320 are releasable Ground connects and and therefore can rinsed independently of framework 3310.Upper arm sleeve pipe 10312 in use covers the plastics of upper arm 10320 Material and prevent the top edge of inner surface and upper arm 10320 and lower edge from directly touching patient facial region.Arm sleeve pipe 10312 woven fabric material soft feel by patient with comfortably and being felt as less " medical science " outward appearance.This can cause Preferable curative compliance.Upper arm sleeve pipe 10312 can be prevented or minimized generally in the treatment duration by upper arm 10320 The facial markers caused, especially patient 1000 are that side is slept rather than slept on one's back.In addition, holding surface heat is not simultaneously for woven fabric material And condensing sweat, this can advantageously compare directly contacting between patient facial region and plastics upper arm 10320.Under imagination Arm 10330 can also have similar arm sleeve pipe 10312.

6.7 mask system

One or more mask parts can be constructed and arranged to together so that conduit torque uncoupling is so that sealing The possibility of interference is minimized.Tubulature 4180 can make conduit torque uncoupling due to its enhanced flexible and expansion service. It can be positioned with the torque of uncoupling and rock-steady structure 3300 also goes conduit torque if conduit torque is more than tubulature 4180 Coupling.The upper arm 10320 of framework 3310 can be bent in sagittal plane so that conduit torque uncoupling.In addition, pumping chamber 3200 And/or sealing forms structure 3100 and will make the conduit torque uncoupling of a part of quantity.It is two or more in these features Any combination, which is improved, makes the ability of conduit torque uncoupling.All the combination of these features enters one and enhanced to make a greater amount of lead The ability of pipe torque uncoupling.

One or more mask parts can construct and be arranged as the comfort level for coming together to improve patient 1000.Tubulature 4180 be that to form structure 3100 with sealing be also lightweight for lightweight and pumping chamber 3200, therefore is not required by positioning and stably The headband tension force that structure 3300 is provided is undesirable high, to provide good sealing.Reduce to tubulature 4180 is connected To framework 3310 bend pipe the need for also reduce the overall weight of patient interface 3000, which reduce by positioning and stable knot The grade of the headband tension force of the requirement of structure 3300.In addition, when patient interface 3000 is light weight, being felt by patient 1000 It is " there almost do not have " so that imperceptible you are just adorning oneself with and cause the patient interface of less anxiety and terrified claustrophobia 3000.Because arm 10320,10330 is located at the lower section of cheekbone and is being probably also sensitive facial for some patients 1000 Seeker counterband tape 3301 around the patient ear in region, therefore the shape of arm 10320,10330 carried for patient 1000 with flexibility Comfortableness is supplied.Headband band 3301 be made up with upper arm sleeve pipe 10312 of textile fabric and due to plastic cap counterband tape phase Holding surface heat and sweat will not made to condense therefore feel good against the skin of patient yet than it.Further, since head Counterband tape 3301 is made up of textile fabric, therefore with causing weight compared with the plastic material that volume reduces, it is less dense.This Two or more any combination in a little features improve the comfortableness of patient 1000.The combination of these whole features is greatly Enhance the comfortableness of patient 1000.

One or more mask parts can construct and be arranged as coming together improving with the optimal seal of patient 1000 can Can property.This may cause more preferable treatment compliance and increase extra 36 minutes in average routine use.As described above Can the improved uncoupling by conduit torque and the combination of the enhanced comfort level further for patient 1000 obtain most Good sealing.In addition, the maximum inclination scope provided by frame arm 10320,10330 improves the possibility of optimal seal.

One or more mask parts can construct and be arranged as coming together to improve causing more preferably for patient interface 3000 Treatment compliance vision attract, for patient 1000 first.Due to framework 3310 be not non-constant width simultaneously And also bend with corresponding to facial geometry and also without forehead support, therefore patient interface 3000 has on patient facial region There are low profile and small space-consuming.Two or more any combination in these features improve regarding for patient interface 3000 Feel aesthetic feeling.All the combination of these features significantly enhances the visual sense of beauty of patient interface 3000.

One or more mask parts can be constructed and the assembling for improving patient interface 3000 that is arranged as coming together is with tearing open Unload.Structure 3100 is formed with headband band 3301 including two from framework 3310 as sealing because patient interface is provided Three mask systems of individual removable section, patient interface 3000 is that patient 1000 provides simplification.Less detachable block is also Mean when patient interface 3000 needs cleaning, easy Assembly And Disassembly patient interface 3000.Framework 3310, pumping chamber 3200/ sealing, which forms structure 3100, can individually clean from headband band 3301 and in different processes, for example, increasing The sealing of pressure chamber 3200/, which forms structure 3100, more frequently being to be rinsed than headband band 3301.The shape of part exists with structure Advise patient 1000 such as how intuitive manner Assembly And Disassembly patient interface 3000 in vision and tactile.For example, working as engagement just The matching relationship that produces between the pumping chamber 3200 of audible click sound and framework 3310 is for patient 1000 when really Intuition.In addition, providing vision and haptic indication on framework 3310, pumping chamber 3200 and positioning and rock-steady structure 3300 Device and provide magnetic head band folder 10210 be patient 1000 increase further guiding with avoid incorrect assembling/dismounting or The fault orientation of mask part/mistake alignment.A part in these features is for may be with arthritic hand in dark It is especially advantageous for patient 1000 in environment.For example, it is low it is light in the case of, audible click be it is audible, The touching of the shape of mask part and tactile indicators is with feeling or magnetic attachment feels to be also useful.In these features Two or more any combination improves the simplicity of patient interface 3000.All the combination of these features is significantly enhanced The simplicity of patient interface 3000.

In an example of this technology, frame assembly 3001 includes framework 3310, tubulature 4180 and blow vent 3400 sub-component.The sub-component of frame assembly 3001 is permanently attached to each other, such as with framework 3310 and tubulature 4180 The blow vent 400 of one is permanently attached to each other.Spacer assembly 3002 is removedly engaged with frame assembly 3001.Pad Component 3002 forms structure 3100 and pumping chamber 3200 including sealing.Headband band 3301 and frame assembly 3001 especially with framework 3310 arm 10320,10330 is removedly engaged.

Figure 131 to Figure 137 shows a kind of form according to this technology including one or more aspects as described above Patient interface multiple views.

6.8 PAP equipment 4000

Machinery and Pneumatic component 4100, electronic unit 4200 are included according to the PAP equipment 4000 of the one side of this technology And it is programmed to carry out one or more algorithms 4300.PAP equipment can have with the shell body 4010 of two part formation, outside The top 4012 of housing 4010 and the bottom 4014 of shell body 4010.In alternative form, shell body 4010 can include One or more panels 4015.PAP equipment 4000 can include one or more internal parts of support PAP equipment 4000 Underframe 4016.Air body block 4020 is supported by underframe 4016 in a form, or is formed as a part for underframe 4016.PAP Equipment 4000 can include handle 4018.

The pneumatic path of PAP equipment 4000 can include inlet air filter 4112, Inlet muffler, can be in malleation The controllable press device (for example, controllable air blower 4142) of lower supply air, and outlet noise silencer.Can be on pneumatic road Footpath includes one or more pressure sensors and flow-sensint unit.

Air body block 4020 can include a part for the pneumatic path being positioned in shell body 4010.

PAP equipment 4000 can have electric energy supply 4210 and one or more input equipments 4220.Electronic unit 4200 It may be mounted on single printed circuit board component (PCBA) 4202.In alternate forms, PAP equipment 4000 can include many In a PCBA4202.

6.8.1 PAP plant machineries ＆ Pneumatic components 4100

6.8.1.1 air cleaner 4110

Air cleaner 4110, or multiple air can be included according to the PAP equipment 4000 of this technology form Filter 4110.

In one form, inlet air filter 4112 is positioned at the pneumatic path upstream of controllable air blower 4142 Section start.Referring to Fig. 3 c.

In a form, outlet air filter 4114, such as antibacterial air filter are positioned at going out for air body block 4020 Between mouth and patient interface 3000.Referring to Fig. 3 c.

6.8.1.2 press device 4140

In the form of this technology, the press device for producing the air stream in malleation is controllable air blower 4142.For example air blower 4142 can be included with the brushless DC motor for being contained in one or more of spiral case propeller.Drum Blower fan 4142 can be in the range of from about 4cm water columns to about 20cm water columns direct draught, or to be up to about 30cm water The form transmission air supply of post, e.g., from about 120 liters/min.

6.9 humidifiers 5000

6.9.1 humidifier is summarized

Humidifier 5000 as shown in figure 3b is provided in a kind of form of this technology, its can include aqua storage tank with Heating plate.

6.10 term

In the particular form of this technology, one or more of it can give a definition using one, for the public affairs of this technology The purpose opened.In the other forms of this technology, interchangeable definition can be applied.

6.10.1 summary

Air：In the particular form of this technology, the air supplied to patient can be atmospheric air, and in this technology Other forms in, can use oxygen supply atmospheric air.

Continuous positive airway pressure (CPAP)：CPAP therapy represents the supply of air or breathable gas on air Continuously for it is positive and preferably during the breath cycle of patient under the pressure of approximately constant arrive air flue entrance application. In some forms, the change that the pressure in the porch to air flue will have several centimeter water columns in single breath cycle, for example Intake period it is higher and during exhaling it is lower.In some forms, the pressure in the porch to air flue will exhale Period is slightly greater and slightly lower in intake period.In some forms, the pressure during the different breath cycles of patient Power will change, for example, increase corresponding to the detection of the instruction of partial upper airway obstruction, and in the finger of partial upper airway obstruction Show and reduce in the case of lacking.

6.10.2 the scheme of PAP equipment

Air loop：Construct and be provided for the air that transmits between PAP equipment and patient interface or can tidal air The conduit or pipeline of the supply of body.Specifically, the gas return path can be fluidly connected with the outlet of air body block and patient interface. Air loop can be referred to as airflow pipe.In some cases, it is understood that there may be for air-breathing and independent time exhaled Road branch.In other cases, using single branch.

APAP:Automatic positive airway pressure.Can be depending on the appearance or missing of the instruction of SDB events in lower limit and the upper limit Between the positive airway pressure that continuously adjusts.

Air blower or flow generator：The equipment that air stream is conveyed with the pressure of projecting environmental pressure.

Controller：The equipment of output or a part for equipment are adjusted according to input.For example, a kind of form of controller --- controlling variable --- with controlled variable, the control variable is formed into the input of equipment.The output of equipment is that control becomes The currency of amount, and variable set point.Servo breathing machine can include controller, and the controller has as the logical of input Gas, as the target ventilation of set point, and is used as the pressure support ventilation grade of output.The input of other forms can be oxygen saturation (SaO2), one in the local pressure of carbon dioxide (PCO2), movement, the signal from photo-plethysmographic figure and peak flow It is individual or multiple.The set point of controller can be fixed, alterable or study.For example, in lung ventilator In set point can be patient measurement ventilation long-term average.Another lung ventilator can have what is changed over time to lead to Gas set point.Pressure controller can be structured as control air blower or pump to convey air with specified pressure.

Treatment:Treatment in the present context can be positive pressure therapy, oxygen therapy, carbon dioxide treatment, the control of dead space System and drug control in one or more.

Motor：Equipment in rotary moving for converting electric energy to component.In this paper environment, revolving part is to promote Device, it rotates to apply pressure to the air moved along rotary shaft around fixing axle at position.

Positive Airway Pressure (PAP) equipment：For the air supply in normal pressure to be provided to the equipment to air flue.

Converter：For a kind of form energy or signal to be converted into alternative equipment.Converter can be used to incite somebody to action Mechanical energy (such as moving) is converted into the sensor or detector of electric signal.The example of converter includes pressure sensor, flow Sensor, carbon dioxide (CO2) sensor, oxygen (O2) sensor, force sensor, movable sensor, sensor noise, appearance Product tracer and camera.

6.10.3 the scheme of exhalation cycle

Apnea：Preferably, it will be considered to breathe when flow drops to predetermined threshold duration such as less than 10 seconds Pause.Think that generation obstructive respiration is temporary when some obstructions of air flue making great efforts although patient still do not allow air mass flow Stop.Think that maincenter breathing is temporary when apnea caused by detecting due to respiratory effort reduction or respiratory effort missing Stop.

Work period：Inspiratory duration Ti and total breathing time Ttot ratio.

Make great efforts (breathing)：Preferably, it is believed that respiratory effort attempts the work that autonomous respiration personnel complete breathed.

The expiration part of respiratory cycle：To the period of inspiratory flow since expiratory gas flow.

Flow restriction：Preferably, flow restriction by be considered as the event in patient respiratory a kind of state, wherein at this The increase made great efforts in state by patient will not produce the corresponding increase of flow.Wherein sent out during the air-breathing part of breath cycle Raw flow restriction, can be described as inspiratory flow limitation.The Flow Limit wherein occurred during the expiration part of breath cycle System, can be described as expiratory gas flow limitation.

Hypopnea：Preferably, hypopnea will may be considered flow reduction, rather than flow interruption.In one kind In form, when during certain duration flow-reduction under threshold value then it is considered that occurring hypopnea.Adult's In a kind of form, below any can be viewed as hypopnea：

(i) interior patient's breathing reduces 30% and adds 4% associated desaturation during at least 10 seconds；Or

(ii) (but being less than 50%) is reduced in patient respiratory during at least 10 seconds, with therewith at least 3% correlation Desaturation or wake-up.

The air-breathing part of respiratory cycle：Preferably since the inspiratory flow to expiratory gas flow cycle will be recognized To be the air-breathing part of breath cycle.

Open (air flue)：The degree of airway open or the scope of airway open.Patient airway is to open.Airway open Can quantify, such as the value with one (1) is open, and the value of zero (0) is closure.

Just terminating breath pressure (PEEP):Exist and the pressure higher than air in lung at the end of expiration.

Peak flow (Qpeak):The maximum of flow during the air-breathing part of respiratory flow waveform.

Respiratory flow, flow, the empty flow of patient, the empty flow (Qr) of breathing:It is appreciated that these synonymous terms are related to PAP The estimation of the respiratory flow of equipment, it is with being used as the actual respiratory flow by patient experience generally represented by Liter Per Minute " true respiratory flow " or " true respiratory flow " is opposite.

Tidal volume (TV) (Vt)：When not applying excessive effort, the air for sucking or breathing out during eupnea Volume.

(air-breathing) time (Ti)：The duration of the air-breathing part of respiratory flow waveform.

(expiration) time (Te)：The duration of the expiration part of respiratory flow waveform.

(total) time (Ttot)：The beginning of air-breathing part in a respiratory flow waveform and next respiratory flow ripple Total duration between the beginning of the air-breathing part of shape.

Typical ventilation recently：A kind of ventilation values, wherein, the most recent value whereabouts on specific scheduled time range is with concentrating Around the ventilation values, that is, the measurement of the central tendency for the most recent value ventilated.

Upper airway obstruction (UAO)：Including part and total Upper airway obstruction.This may be related to the state of flow restriction, its In, the grade of flow only slightly increases or reduced even as the pressure differential on epithelium healing increases in flow restriction (behavior of Starling resistance gauges).

Ventilate (blow vent)：The measurement of the total amount of the gas exchanged by patient breathing system, including time per unit Air-breathing and expiratory gas flow.When being expressed as volumes per minute clock, this amount is commonly referred to as " minute ventilation ".It is sometimes only simple Ground provides minimum throughput as volume, it can be understood as volume per minute.

6.10.4 PAP device parameters

Airflow rate：The instantaneous volume (or quality) of the air of time per unit conveying.Although flow velocity has with ventilation Time per unit identical volume size or quality, but measure flow velocity in shorter period.For exhaling for patient Flow can be nominally positive for inhaling the air-breathing part of circulation, and for the expiration part of the breath cycle of patient It is negative.In some cases, involved flow velocity will be related to the amount that scalar only has value.It is involved in other situations And will be related to the amount that vectorial quantity has value and direction to flow velocity.Give flow symbol Q.Total flow Qt is to leave PAP The flow of the air of equipment.Ventilation flow rate, Qv is to leave blow vent to allow the flow washed away of exhaled gas.Reveal flow, Ql, is the flow velocity with outward leakage from patient interface systems.Respiratory flow Qr, is the air received in patient breathing system Flow.

Leakage：Preferably, term leakage will be considered as flow to the air of surrounding environment.Leakage can do it on purpose, For example, to allow to breathe out washing away for CO2.Leakage can be unintentionally, for example, due to endless between mask and patient facial region It is hermetically sealed.

Pressure：The power of per unit area, can be including cm water columns, g-f/cm², hundred Pascals unit range in measure Pressure.1cm water columns are equal to 1g-f/cm²And close to 0.98 hundred Pascals.In this description, unless otherwise indicated, pressure with The unit of cm water columns is provided.It is related to about 4-20cm water columns or big for the treatment pressure involved by OSA nasal CPAP treatment Pressure in the range of about 4-30cm water columns.Pressure in patient interface gives symbol Pm.

Sound power：The energy of time per unit is carried by sound wave.Sound power is multiplied by the face of wavefront with sound pressure Long-pending square proportional.Generally with decibel SWL i.e. with generally 10^-12The reference power that is obtained at watt related decibel is given Go out sound power.

Sound pressure：It is local inclined from environmental pressure caused by Medium Propagation because sound wave passes through in given time Difference.Generally with decibel SPL i.e. with generally in the 2x10 for the threshold values for being considered mankind's hearing^-6The reference that Pascal (Pa) place is obtained Power related decibel provides sound power

6.10.5 facial anatomy

The wing (ala)：The outer wall or " wing " (plural number in each nostril：alar)

Wing of nose end：The point of most side on the wing of nose.

Wing curvature (or wing peak) point：Rearmost point in the baseline of the bending of each wing, wherein, by cheek and the wing Joint portion formed fold in find the point.

Auricle or auricle：The whole visible outside of ear.

(nose) bone framework:The bone framework of nose includes nasal bone, and the volume of maxilla is prominent and nose of frontal bone.

(nose) cartilage framework：The cartilage framework of nose includes nasal septal cartilage, flank cartilage, big cartilage and small cartilage..

Nose pillar：Separate nostril and the strip band of upper lip is extended to from pn.

Nose small roll angle：By nose cut outs the lines drawn by midpoint with perpendicular to Frankfort level simultaneously with arm Angle between the drawn lines of point.

Frankfort horizontal plane：The line of left tragus point is extended to from the most subordinate point of margo orbitalis.Tragus point is to surmount ear Point most deep in the recess of wide tragus point.

Glabella：It is positioned on parenchima, the most salient point in the central sagittal plane of forehead.

Lamina dorsi nasi：The plate shape organ of the generally triangle of cartilage.Its upper limb is attached to the volume of nasal bone and maxilla It is prominent, and its lower edge is connected to larger nasal alar cartilage.

Greater alar cartilage：Plate shape organ below lamina dorsi nasi.It bends around the previous section in nostril.It The volume that rear end is connected to maxilla by the rough wearing fiber barrier film of the three or four small cartilages including the wing is dashed forward.

Nostril (nose hole)：Form the perforation of the approximate ellipsoidal of the entrance of stomata cavity.The list in nostril (nares) Number form formula is nostril (naris) (nose hole).Nostril is separated by nasal septum film.

Nasolabial groove or muffle fold：A crease in the skin or groove extend to the corners of the mouth from each side of nose, make cheek with it is upper Lip is separated.

Nasal labial angle：Angle is between pillar and upper lip, by intersecting with subnasale.

Basic point on ear：Lower attachment point of the auricle to the skin of face.

Basic point on ear：Upper attachment point of the auricle to the skin of face.

Pn：The most salient point or tip of nose, can recognize it in the side view of the remainder on head.

In people：The middle line groove at the top of the lip extended to from the lower boundary of nasal septum film in upper lip area.

Pogonion：It is positioned on the soft tissue of foremost intermediate point of chin.

(nose) beam:The bridge of the nose is the center line protuberance for the nose that pn is extended to from the nasion.

Sagittal plane：Pass through the perpendicular of (rear end) below by body from above (front end) and be divided into right side and left half Portion.

The nasion：It is positioned on soft tissue, covers the most recessed point in the region of frontonasal suture.

Septal cartilage (nose)：A part for nasal septal cartilage formation barrier film and the front portion for splitting nasal cavity.

Postalifera：In the skin engagement of the point of the lower edge of wing of nose base portion, wherein wing of nose base portion and upper (upper end) lip.

Subnasal point：It is positioned on soft tissue, the point that pillar is combined with the upper lip in central sagittal plane.

Pogonion:The point of maximum cavity in the center line that lower lip stitches the lower lip between soft tissue pogonion.

6.10.6 the anatomy of skull

Frontal bone：Frontal bone includes big vertical portion, and frontal squama is corresponding to the region of referred to as forehead.

Mandibular：Lower jaw bon e formation lower jaw.Mental protuberance is that the apophysis in the jaw portion to form chin goes out.

Maxilla：The upper jaw bon e formation upper jaw and it is positioned above mandibular and below eye socket.The volume of maxilla is dashed forward Up protruded in the side of nose, and form a part for its lateral boundaries.

Nasal bone:Oval bone two small during nasal bone, change in size and forms Different Individual；They are arranged side by side in face The middle part and top in portion, and by their intersection, form " beam " of nose.

Nasion:Os prefrontale intersects with two nasal bones, and sunk area is directly between eye and more than the bridge of the nose.

Occipital bone：Occipital bone is positioned at the rear portion and bottom of skull.It includes ellipse perforation, occipital bone punching, passes through its skull Cavity and canalis spinalis UNICOM.Twisted plate behind foramen magnum is occipital squama.

Eye socket：The bone cavity body in skull for accommodating eyeball.

Parietal bone：Parietal bone is the bone at the top and side that form skull when engaged together.

Temporal bone：Temporal bone is positioned on the base portion and side of skull, and supports referred to as temporal facial part.

Cheekbone：Face includes two cheekbones for being positioned in the top of face and sidepiece and being formed the protrusion of cheek.

6.10.7 the anatomy of respiratory system

Diaphragm：The muscle layer extended across thoracic cavity bottom.Diaphragm is by thoracic cavity and abdominal cavity including heart, lung and flank Separation.When diaphragm shrinks, the volume in thoracic cavity increases and air is inhaled into lung.

Larynx：Larynx or larynx accommodate vocal cords and are connected pharyngeal bottom (hypopharynx) with tracheae.

Lung:The organ of breathing in human body.The conductive area of lung is comprising trachea-bronchial epithelial cell, bronchiole and end is thin eventually Bronchus.Breathing area includes respiratory bronchiole, alveolar ducts and alveolar.

Nasal cavity：Nasal cavity (or nose alveole) is big air filling sky on the nose at the middle part of face and below Between.Nasal cavity is divided into two by the vertical fin for being referred to as nasal septum.There are three levels on each side in nostril Grow portion, be referred to as external ear (conchae, its singulative be concha) or turbinate.It is nose in front of nasal cavity, and The rear of nasal cavity is bent in nasopharynx via choana.

It is pharyngeal：Being sitting at below nasal cavity of throat (under) and oesophagus and throat above part.It is pharyngeal generally to be divided It is segmented into three parts：Nasopharynx (epipharynx) (pharyngeal nose), oropharynx (middle pharynx) and laryngopharynx (hypopharynx).

6.10.8 material

Silicones or silicone rubber：A kind of synthetic rubber.In this manual, involved silicones is related to liquid silicon Resin rubber (LSR) or compression molding silicone rubber (CMSR).A form of commercially available LSR is by Dow Corning The SILASTIC (being included in a series of products sold under the trade mark) of manufacture.LSR another manufacture thing is Wacker. LSR preferred form is had as pressed using the scope measured by ASTM D2240 in about 35 to about 45 Shore A (or A classes) Trace hardness.

Makrolon：A kind of thermoplastic polymers of the normally transparent of bisphenol-A carbonate.

6.10.9 the scheme of patient interface

Anti- asphyxia valve (AAV)：The component or sub-component of mask system, it is opened by way of with error protection to air Open, reduce the risk of the transition carbon dioxide rebreathing of patient.

Bend pipe：The axle of air-flow is instructed to change nyctitropic conduit by angle.In a form, angle can approximate 90 Degree.In another form, angle can be less than 90 degree.Conduit can have approximate circle cross section.In another form In, conduit can have the cross section of ellipse or rectangle.

Framework：The tension force that frame representation is used to bear and position between two or more tie points of rock-steady structure is carried The face mask structure of lotus.Mask frame can be the load bearing construction of the non-hermetically sealed in mask.However, some form of mask frame Frame can be airtight.

Positioning and rock-steady structure：Positioning and rock-steady structure represent to designed to be used a form of positioning on head and steady Determine structure.Positioning and rock-steady structure preferably include the set of one or more depression bars, frenulum and hard thing, are configured as patient Interface is placed and is maintained in the position on patient facial region, so as to the conveying of respiratory therapy.Some frenulums are by soft, flexible , the thin slice synthetic of material such as foam fabric of elasticity is manufactured into.

Barrier film：Barrier film represents preferably have resistive logical for stretching essentially for no resistance is bent Often thin element.

Pumping chamber：Mask plenum represents a part for patient interface, and the part has the wall of packaging space volume, the body There is the air for being pressurized to superatmospheric in use in product.Housing can form a part for the wall of mask plenum. In a form, the region of patient facial region forms a part for the wall of pumping chamber.

Sealing：Its title form (" seal ") represents structure of the intentionally resistance by the air-flow of the interface on two surfaces Or barrier.Verb form (" sealing ") represents resistance air-flow.

Housing：Housing preferably represents the warp architecture of tractile and compressible hardness with bending, for example The part for being used to form the warp architecture wall of mask of mask.Compared with out to out, it is preferably thinner.In some forms, Housing is that tool is faceted.The wall is preferably airtight, but in some forms they can not be it is airtight.

Hardware：Hardware represents to be designed to increase the structure of the compression resistance power of another component at least in one direction Component.

Depression bar：Depression bar is used as a kind of structure member, and it is designed as increasing the resistance to of another part at least one direction Pressure property.

Rotary body：(noun) is configured as on common axis preferably separately and preferably in the backspin of small moment of torsion The sub-component of the component turned.In a form, rotary body may be constructed such that at least 30 degree of angle is passed through in rotation.Another In one form, rotary body may be constructed such that at least 360 degree of angle is passed through in rotation.When in the environment in air delivery conduit In use, the sub-component of the component preferably includes the tubular conduit pair of matching.Almost do not have preferably in the use of rotary body Leaked with and without air-flow from it.

Frenulum：Frenulum is designed to resist the construction package of tension force.

Blow vent：(noun) structure allows intentional, speed of the air from the inside of mask or conduit to surrounding air Controlled leakage, with the supply washed away with oxygen (O2) of (CO2) of allowing to give off carbon dioxide.

6.10.10 the term used in patient interface

(surface) curvature：The region with saddle type on surface, it is upper curved in one direction and in different directions Under it is curved, be referred to as with negative cruvature.The region with cheese on surface, it is curved in the same manner in two Main ways Song, will be referred to as with positive camber.Flat surfaces have zero curvature.

Soft：The quality of the material, structure or the synthetic that are combined with following characteristics：

A) finger pressure is easily catered to.

B) when causing it to support the weight of its own, it can not keep its shape.

C) it is nonrigid.

D) easily flexibly stretch or bend.

There can be related direction with soft quality, therefore specific material, structure or synthetic can be first It is soft in direction but is hard or rigid in the second direction such as second direction orthogonal with first direction.

It is springy：Can substantially it be resiliently deformed and in unloading within relatively short time cycle such as 1 second Substantially all energy are discharged afterwards.

It is rigid：When erectting and maintaining patient interface with the sealing relationship to the entrance of patient airway, it is not easy to quilt Generally predetermined finger pressure and/or tension force or deformation under load.

It is semirigid：Mean it is sufficiently rigid with the effect of mechanical force that is commonly applied during positive airway pressure is treated it Under be substantially inflexible.

6.11 other remarks

A disclosed part for patent document includes material protected by copyright.Copyright owner does not oppose by this specially The disclosed reproduction that anyone is carried out of sharp document or this patent, because it appears in the patent document or note of patent and trademark office In record, but retain so copyright.

Unless it is not such or there is provided a series of values that context, which is explicitly indicated, be otherwise appreciated that scope the upper limit and Between lower limit to lower limit unit tenths each median and the scope in any described in other or median It is included in this technique.These medians can be included in by the upper and lower bound being independently include in intermediate range In this technology, unless had any limitation specifically excluded in the scope.Include one or amount limit in the scope In the case of system, it is not also included in including the scope of one or two in these limitations in this technology.In addition, herein In the case of the part that value is expressed as to being implemented as this technology, it is understood that the value can be it is approximate, unless otherwise indicated Be not so, and the value can be used for any appropriate effective digital, as long as particular technique application allow or need.One should be entered Step understands that arbitrary value and all described values can be up to 10-20% from the value changes.

All technologies as described herein and scientific terminology have with technology those of ordinary skill in the art institute generally The implication identical implication of understanding, is not so unless stated otherwise.Although identical with those described methods and material or wait Any means and material of effect can also be used for the implementation and test of this technology, but this document describes the exemplary side of limited quantity Method and material.

It is obvious replaceable with similar characteristic when specific material is considered as being preferably used for construction component Material can be used as replacing.In addition, as described herein any and all component be understood to individually to be constructed or manufactured or Person is constructed or is manufactured in together, and is not so unless otherwise specified.

It has to be noticed that such as including it in singulative " one ", " one " and the "the" imposed herein and in claim Plural equivalent, unless it is not so that context, which is explicitly indicated,.

By reference to mode all disclosures as described herein are incorporated herein, and they describe those disclosed themes Method and/or material.Disclosure as described herein is provided to be only used for their disclosures before the date of filing of the application.Should not Anything herein is construed to allow this technology not have the qualification earlier than the disclosure.In addition, what is provided is disclosed Date can be different from actual publication date, wherein, it may be necessary to independently confirm the actual publication date.

In addition, when explaining disclosure herein, it should explain all with the rational method of most wide area consistent with the context Term.Specifically, term " comprising " and "comprising" should be interpreted to be related to element, component or step in non exhaustive mode Suddenly, for indicating that involved element, component or step can be together with for the other elements referred explicitly to, component or step Occur or utilize or combine.

The topic headings used in detailed description for the ease of reader's reference and be included and bel not applied to limit The theme found through open or claim.Topic headings bel not applied to explain claim or scope or claim Limit.

Although describing this paper technology with reference to instantiation, it is to be appreciated that these examples are merely illustrative technology Principle and application.In some cases, term and symbol can imply that the unwanted detail of implementation technology institute.For example, Although term " first " and " second " can be used, they are not intended for indicating any order but in different members Made a distinction between part, be not so except as otherwise noted.In addition, although can in order describe or the process of illustration method is walked Suddenly, but the order is not essential.Those skilled in the art will be recognized that the order can be changed and/or can Simultaneously or even synchronously to perform its scheme.

It is understood, therefore, that a large amount of modifications can be made to shown example, and the spirit and scope of the technology are not being departed from On the premise of it is contemplated that other configurations.

Reference numerals list

Winding pipe assembly 120

Headband connector 156

Attachment area 158

Sealing area 251

Nasal bridge region 252

Nose lateral side regions 253

Naricorn region 254

Upper lip area 255

Interior (preceding) edge 260 (i)

(rear) edge 260 (0) outside

Barrier film 260-1

Barrier film 260-2

Barrier film 260-3

End liner mat structure 265

Sealing sheet 270

Throttle orifice 275

Upper Orifice portion 275 (1)

Lower Orifice portion 275 (2)

Outward flange 280 (i)

Inward flange 280 (o)

Sidewall areas 457

Triangular perimeter region 720

Y shape headband connector 800

Draw to lead to and prevent structure 791

Top counterband tape tie point 810

Following counterband tape tie point 820

Shackle bindiny mechanism 950

Patient 1000

Bed is with 1100

Patient interface 3000

Frame assembly 3001

Spacer assembly 3002

Spacer assembly 3003

Spacer assembly 3005

Sealing forms structure 3100

Nose stretcher 3101

Top sealed portion 3102

Sealing portion point 3104

Sealing flange 3110

Support lugn 3120

Pumping chamber 3200

Coupling part 3202

Periphery 3120

Tongue-like part 3211

Channel part 3211.1

Framework join domain 3213

Margin 3220

It is pressurized join domain 3240

Holding structure 3242

Wide keeping characteristics 3244

Narrow keeping characteristics 3245

Crook 3246

Preceding surface 3246.1

Surface 3246.2 afterwards

Nominal vertical axle 3246.4

Sealing lip 3250

Flank 3294

Recess 3295

Positioning and rock-steady structure 3300

Headband band 3301

Framework 3310

Wide framework join domain 3312

Import surface 3312.1

Holding surface 3312.2

Narrow framework join domain 3313

Hinder part 3314

Blow vent 3400

Passage 3405

Connectivity port 3600

PAP equipment 4000

External shell 4010

The top 4012 of external shell

The bottom 4014 of external shell

Panel 4015

Underframe 4016

Handle 4018

Air body block 4020

Pneumatic assembly 4100

Air cleaner 4110

Inlet air filter 4112

Outlet air filter 4114

Press device 4140

Controllable air blower 4142

Air loop 4170

Web material 4172

Spiral winding 4174

The inside 4176 of bending

Long duct 4178

The outside 4179 of bending

Tubulature 4180

Protrusion 4181

The peak dot 4182 of folding part

Rake 4183

The outer surface 4184 of spiral winding

Feed oxygen gas port 4185

Broken line 4186

Rotary guide pipe set 4190

Electronic unit 4200

Printed circuit-board assembly

4202

(PCBA)

Power supply supply 4210

Input equipment 4220

Algorithm 4300

Humidifier 5000

Headband folder 10210

Mechanical holding member 10215

Magnet 10216

Space 10217

Cross bar 10218

Following counterband tape 10220

Lower coupling part 10221

Upper coupling part 10222

Thinning coupling part 10223

Apical cap band 10225

It is preced with band 10226 in side

Neck band 10227

Main lateral edges 10228

Main lateral edges 10229

Top counterband tape 10230

Secondary lateral edges 10231

Secondary lateral edges 10232

Top frame tie point 10305

Elongated spaces 10306

First bending sections 10307

First bending 10308

Straightforward face 10309

Second bending 10310

Second bending sections 10311

Upper arm sleeve pipe 10312

Narrow middle section 10313

Ring 10315

Fastener 10316

Underarm tie point 10317

Upper arm 10320

Distally 10323

Upper headband tie point 10325

Underarm 10330

Lower headband tie point 10331

Convex surface 10335

Magnet 10340

Outer radial wall 10350

Interior radial wall 10351

Radial passage 10352

Stop surface 10353

Track 10355

Annular rib 10360

Tubulature sheathed catheter 10610

Groove 10611

7.1 patent document

Claims (32)

1. a kind of positioning and the headband folder of rock-steady structure for patient interface, including：

Mechanical structure, when applying headband tension force, it presss from both sides the headband headband tie point for being mechanically coupled to frame assembly And allow the headband folder relative to headband tie point rotation；

Magnet, it makes the headband folder magnetically be engaged with the headband tie point；And

Slit, it is used to receive the headband band passed through,

Wherein, when applying headband tension force, the mechanical structure prevents the headband to be clipped in and Frankfort horizontal direction essence Linear displacement in upper parallel direction,

Wherein, the mechanical structure includes convex wall, and the convex wall limits the space for being suitable to receive the headband tie point；And

Wherein, the mechanical structure include outer engagement surface, the outer engagement surface substantial smooth so that any Relative friction and Physical obstacle is minimized, thus allows readily to rotate against.

2. headband folder as claimed in claim 1, wherein, the convex wall is semicircle, and the headband tie point includes cylinder Shape part, the cylindrical portion is provided with the convex surface for being configured to engage the convex wall.

3. the headband folder as described in any one in claim 1 to 2, wherein, the magnet passes through top layer plastic material and bottom Layer plastic material is maintained in the headband folder.

4. headband folder as claimed in claim 3, wherein, the convex wall is protruded away from the bottom plastic material.

5. headband folder as claimed in claim 4, wherein, the convex wall is protruded from the circumferential section around the magnet.

6. headband folder as claimed in claim 5, wherein, the convex wall has semi-circular cross-section.

7. headband folder as claimed in claim 3, wherein, the magnet is packed in a plastic material completely.

8. as described in any one in claim 1,2 and 4 to 7 headband folder, wherein, the slit be it is elongated, it is described narrow It is parallel with nominal vertical axle that seam is in use orientated its longitudinal axis.

9. the headband folder as described in any one in claim 1,2 and 4 to 7, wherein, when headband folder and the headband connect When contact engages and applies headband tension force, the slit is unimpeded by the frame assembly.

10. the headband folder as described in any one in claim 1,2 and 4 to 7, wherein, the headband tie point includes magnet.

11. headband folder as claimed in claim 10, wherein, the magnet of the headband tie point is packaged in plastics completely In material.

12. headband as claimed in claim 11 folder, wherein, the magnet of the headband tie point is packaged in described completely In the underarm of frame assembly.

13. headband folder as claimed in claim 4, wherein, the headband tie point is the underarm projection from the frame assembly Convex surface so that when applying headband tension force, the headband tie point is against the convex wall.

14. the headband folder as described in any one in claim 12 to 13, wherein, when the length by adjusting the headband band Spend to apply during headband tension force, the headband folder maintains mechanical and magnetic the engagement with the underarm and relatively described Underarm rotates.

15. headband folder as claimed in claim 10, wherein, the magnet of the headband folder and/or the headband tie point It is ferromagnet, permanent magnet or electromagnet.

16. a kind of patient interface, for sealing breathable gas stream under the continuous normal pressure relative to environmental air pressure The entrance of at least patient airway including patient nostril entrance is transported to, wherein, the patient interface is configured as running through patient The respiratory cycle of patient during sleep, treatment pressure is kept in use in the 4cm water columns higher than environmental air pressure to 30cm In the range of water column, to improve sleep disorders；

The patient interface includes：

Spacer assembly, it includes being suitable for forming the air flue of the patient sealedly sealing forming structure and in use quilt It is pressurized to the pumping chamber under the pressure higher than environmental pressure；

Positioning and rock-steady structure, it is used to maintain the spacer assembly with surrounding to the close of the region of the entrance of the patient airway Sealing-in is touched, while maintaining the treatment pressure of the porch of the patient airway；

Gas discharges blow vent, and it is configured as the CO for allowing patient to breathe out₂The outside of the patient interface is flow to, so that right The CO breathed out by the patient₂Re-breathing minimize；

Frame assembly, it is separably engaged the spacer assembly and provided to the positioning and the connection of rock-steady structure；With And

Headband folder as described in any one in claim 1 to 15.

17. patient interface as claimed in claim 16, wherein, the spacer assembly includes holding structure, the holding structure For repeatably engaging and repeatably departing from from frame assembly with the frame assembly, and the frame assembly and institute State holding structure to be made up of semi-rigid material, connected with providing separable hardware to hardware.

18. patient interface as claimed in claim 17, wherein, the spacer assembly is included when the holding structure and the framework Sealed sealing lip is carried out when component is attached to one another to the frame assembly, and when the air pressure in the spacer assembly increases Added-time, the sealing force increase.

19. the patient interface as described in any one in claim 16 to 18, in addition to for conveying forced air or can breathe The conduit of gas supply, the conduit is connected to the frame assembly in the case of no swivel elbow.

20. patient interface as claimed in claim 19, wherein, the conduit is permanently attached to the frame assembly.

21. a kind of device for being used to treat respiratory disorder, including：

Patient interface as described in any one in claim 16 to 20；

Air loop；And

Air-source under normal pressure.

22. a kind of framework for patient interface, the patient interface is used to convey forced air or breathable gas supply To the entrance of patient airway, the framework includes：

Main body；

A pair of upper arm, it extends from the top of the main body,

A pair of underarms, it extends from the bottom of the main body；

Each of the underarm includes lower headband tie point in its far-end,

Wherein, each lower headband tie point includes magnet, and the magnet configurations are the positioning and stable knot with the patient interface Structure is magnetically connected；

Wherein, each lower headband tie point includes mechanical structure, and when applying headband tension force, it is by the positioning and rock-steady structure It is mechanically coupled to the lower headband tie point and allows the positioning and rock-steady structure relative to the lower headband tie point Rotation.

23. framework as claimed in claim 22, wherein, the pair of upper arm is provided with a pair of relative upper headband tie points.

24. framework as claimed in claim 22, wherein, the magnet set to underarm separates the pad set than the patient interface The Breadth Maximum of part is farther.

25. a kind of headband system for patient interface, the patient interface is used to supply forced air or breathable gas The entrance of patient airway is transported to, the headband system includes：

Headband is pressed from both sides, and its setting takes to the positioning of the patient interface and the headband bar of rock-steady structure, and the headband folder includes magnetic Body；And

Framework as described in any one in claim 22 to 24, wherein, the magnet configurations of headband folder for institute The magnet for stating headband tie point is magnetically connected.

26. headband system as claimed in claim 25, wherein, the headband folder is configured to mechanically and magnetically engage the head Band tie point and allow headband folder relative to headband tie point rotation.

27. a kind of patient interface, for conveying breathable gas stream under the continuous normal pressure relative to environmental air pressure To the entrance for the patient airway at least including patient nostril entrance, wherein, the patient interface is configured as running through patient sleeps When patient respiratory cycle, in use keep treatment pressure in the 4cm water columns higher than environmental air pressure to 30cm water columns In the range of, to improve sleep disorders；

The patient interface includes：

Spacer assembly, it includes being suitable for forming the air flue of the patient sealedly sealing forming structure and in use quilt It is pressurized to the pumping chamber under the pressure higher than environmental pressure；

Positioning and rock-steady structure, it is used to maintain the spacer assembly with surrounding to the close of the region of the entrance of the patient airway Sealing-in is touched, while maintaining the treatment pressure of the porch of the patient airway；

Gas discharges blow vent, and it is configured as the CO for allowing patient to breathe out₂The outside of the patient interface is flow to, so that right The CO breathed out by the patient₂Re-breathing minimize；And

Framework as described in any one in claim 22 to 26.

28. patient interface as claimed in claim 27, wherein, the spacer assembly includes holding structure, the holding structure For repeatably engaging and repeatably departing from from framework with the framework, and the framework and the holding structure by Semi-rigid material is constituted, and is connected with providing separable hardware to hardware.

29. patient interface as claimed in claim 28, wherein, the spacer assembly is included when the holding structure and the frame Sealed sealing lip is carried out to the framework when frame is attached to one another, and when the air pressure increase in the spacer assembly, The sealing force increase.

30. the patient interface as described in any one in claim 27 to 29, in addition to for conveying forced air or can exhale The conduit of air-breathing body supply, the conduit is connected to the framework in the case of no swivel elbow.

31. patient interface as claimed in claim 30, wherein, the conduit is permanently attached to the framework.

32. a kind of device for being used to treat respiratory disorder, including：

Patient interface as described in any one in claim 27 to 31；

Air loop；And

Air-source under normal pressure.